Optical bundle apparatus and method for optical and/or electrical nerve stimulation of peripheral nerves

ABSTRACT

Apparatus and method for making and using devices that generate optical signals, and optionally also electrical signals in combination with one or more such optical signals, to stimulate (i.e., trigger) and/or simulate a sensory-nerve signal in nerve and/or brain tissue of a living animal (e.g., a human), for example to treat nerve damage in the peripheral nervous system (PNS) or the central nervous system (CNS) and provide sensations to stimulate and/or simulate “sensory” signals in nerves and/or brain tissue of a living animal (e.g., a human) to treat other sensory deficiencies (e.g., touch, feel, balance, visual, taste, or olfactory) and provide sensations related to those sensory deficiencies, and/or to stimulate (i.e., trigger) and/or simulate a motor-nerve signal in nerve and/or brain tissue of a living animal (e.g., a human), for example to control a muscle or a robotic prosthesis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This invention claims benefit under 35 U.S.C. §119(e) of

-   U.S. Provisional Patent Application No. 61/349,810 filed May 28,    2010, by Jonathon D. Wells et al., titled “Implantable Infrared    Nerve Stimulation Devices for Peripheral and Cranial Nerve    Interfaces”;-   U.S. Provisional Patent Application No. 61/349,813 filed May 28,    2010, by Jonathon D. Wells et al., titled “Laser-Based Nerve    Stimulators for, e.g., Hearing Restoration in Cochlear Prostheses”;-   U.S. Provisional Patent Application No. 61/381,933 filed Sep. 10,    2010, by Jonathon D. Wells et al., titled “Laser-Based Nerve    Stimulators for, e.g., Hearing Restoration in Cochlear Prostheses”;    and-   U.S. Provisional Patent Application No. 61/386,461 filed Sep. 24,    2010, by Jonathon D. Wells et al., titled “Implantable Infrared    Nerve Stimulation Devices for Peripheral and Cranial Nerve    Interfaces”;-   each of which is incorporated herein by reference in its entirety.

RELATED APPLICATIONS

The present invention is related to the following prior applications andpatents:

-   U.S. Provisional Patent Application No. 60/715,884 filed Sep. 9,    2005, titled “Apparatus and Method for Optical Stimulation of    Nerves”;-   U.S. Provisional Patent Application No. 60/826,538 filed Sep. 21,    2006, titled “Miniature Apparatus and Method for Optical Stimulation    of Nerves and Other Animal Tissue”;-   U.S. Provisional Patent Application No. 60/872,930 filed Dec. 4,    2006, titled “Apparatus and Method for Characterizing Optical    Sources used with Human and Animal Tissues”;-   U.S. Provisional Patent Application No. 60/884,619 filed Jan. 11,    2007, titled “Vestibular Implant Using Infrared Nerve Stimulation”;-   U.S. Provisional Patent Application No. 60/885,879 filed Jan. 19,    2007, titled “Hybrid Optical-Electrical Probes”;-   U.S. Provisional Patent Application No. 60/964,634 filed Aug. 13,    2007, titled “VCSEL Array Stimulator Apparatus and Method for Light    Stimulation of Bodily Tissues”;-   U.S. Provisional Patent Application No. 61/015,665 filed Dec. 20,    2007, titled “Laser Stimulation of the Auditory System at 1.94 μm    and Microsecond Pulse Durations”;-   U.S. Provisional Patent Application No. 61/081,732 filed Jul. 17,    2008, titled “Method and Apparatus for Neural Signal Capture to    Drive Neuroprostheses or Bodily Function”;-   U.S. Provisional Patent Application No. 61/102,811 filed Oct. 3,    2008, titled “Nerve Stimulator and Method using Simultaneous    Electrical and Optical Signals”;-   U.S. Provisional Patent Application No. 61/147,073 filed Jan. 23,    2009, titled “Optical Stimulation Using Infrared Lasers (or In    Combination with Electrical Stimulation) of the Auditory Brainstem    and/or Midbrain”;-   U.S. patent application Ser. No. 11/257,793 filed Oct. 24, 2005,    titled “Apparatus for Optical Stimulation of Nerves and Other Animal    Tissue” (which issued as U.S. Pat. No. 7,736,382 on Jun. 15, 2010);-   U.S. patent application Ser. No. 11/536,639 filed Sep. 28, 2006,    titled “Miniature Apparatus and Method for Optical Stimulation of    Nerves and Other Animal Tissue” (which issued as U.S. Pat. No.    7,988,688 on Aug. 2, 2011);-   U.S. patent application Ser. No. 11/948,912 filed Nov. 30, 2007,    titled “Apparatus and Method for Characterizing Optical Sources Used    with Human and Animal Tissues”;-   U.S. patent application Ser. No. 11/536,642 filed Sep. 28, 2006,    titled “Apparatus and Method for Stimulation of Nerves and Automated    Control of Surgical Instruments”;-   U.S. patent application Ser. No. 11/971,874 filed Jan. 9, 2008,    titled “Method and Vestibular Implant using Optical Stimulation of    Nerves” (which issued as U.S. Pat. No. 8,012,189 on Sep. 6, 2011);-   U.S. patent application Ser. No. 12/018,185 filed Jan. 22, 2008,    titled “Hybrid Optical-Electrical Probes” (which issued as U.S. Pat.    No. 7,883,536 on Feb. 8, 2011);-   U.S. patent application Ser. No. 12/191,301 filed Aug. 13, 2008,    titled “VCSEL Array Stimulator Apparatus and Method for Light    Stimulation of Bodily Tissues” (which issued as U.S. Pat. No.    8,475,506 on Jul. 2, 2013);-   U.S. patent application Ser. No. 12/505,462 filed Jul. 17, 2009,    titled “Apparatus and Method for Neural-Signal Capture to Drive    Neuroprostheses or Control Bodily Function”;-   U.S. patent application Ser. No. 12/573,848 filed Oct. 5, 2009,    titled “Nerve Stimulator and Method using Simultaneous Electrical    and Optical Signals” (which issued as U.S. Pat. No. 8,160,696 on    Apr. 17, 2012);-   U.S. patent application Ser. No. 12/693,427 filed Jan. 25, 2010,    titled “Optical Stimulation of the Brainstem and/or Midbrain,    including Auditory Areas” (which issued as U.S. Pat. No. 8,744,570    on Jun. 3, 2014);-   U.S. patent application Ser. No. 12/890,602 filed Sep. 24, 2010 by    Jonathon D. Wells et al., titled “Laser-Based Nerve Stimulators for,    e.g., Hearing Restoration in Cochlear Prostheses” (which issued as    U.S. Pat. No. 8,792,978 on Jul. 29, 2014);-   U.S. patent application Ser. No. 13/117,121 filed May 26, 2011 by    Jonathon D. Wells et al., titled “IMPLANTABLE INFRARED NERVE    STIMULATION DEVICES FOR PERIPHERAL AND CRANIAL NERVE INTERFACES”;-   U.S. patent application Ser. No. 13/117,122 filed May 26, 2011 by    Jonathon D. Wells et al., titled “Cuff Apparatus and Method for    Optical and/or Electrical Nerve Stimulation of Peripheral Nerves”    (which issued as U.S. Pat. No. 8,652,187 on Feb. 18, 2014); and-   U.S. patent application Ser. No. 13/117,125 filed May 26, 2011 by    Jonathon D. Wells et al., titled “Optical Bundle Apparatus and    Method for Optical and/or Electrical Nerve Stimulation of Peripheral    Nerves” “Nerve-Penetrating Apparatus and Method for Optical and/or    Electrical Nerve Stimulation of Peripheral Nerves”;    each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to laser stimulation of animal tissues andmore particularly to lasers and methods for making and using devicesthat generate optical signals, and optionally also electrical signals incombination with one or more such optical signals, to stimulate (i.e.,trigger) and/or simulate a sensory-nerve signal in nerve and/or braintissue of a living animal (e.g., a human), for example to treat nervedamage in the peripheral nervous system (PNS) or the central nervoussystem (CNS) and provide sensations to stimulate and/or simulate“sensory” signals in nerves and/or brain tissue of a living animal(e.g., a human) to treat other sensory deficiencies (e.g., touch, feel,balance, visual, taste, or olfactory) and provide sensations related tothose sensory deficiencies, and/or to stimulate (i.e., trigger) and/orsimulate a motor-nerve signal in nerve and/or brain tissue of a livinganimal (e.g., a human), for example to control a muscle or a roboticprosthesis.

BACKGROUND OF THE INVENTION

FIG. 1A is a schematic diagram 101 of a nerve (adapted fromwww.mayoclinic.org/peripheral-nerve-tumors-benign/diagnosis.html). Anerve 11 contains fascicles (bundles) 12 of individual nerve fibers 13of neurons. FIG. 1B is a schematic diagram 102 of the structure of aspinal nerve 11 that includes its surrounding epineurium 14, whichincludes connective tissue and blood vessels 15, one or more fascicles(fasciculus) 12, each of which is surrounded by perineurium 17. Within afascicle 12 is a plurality of axons 13 each having a myelin sheathsurrounded by endoneurium tissue 18 (credit to internet sources-dataobtained from: en.wikipedia.org/wiki/Nerve_fascicle andtrc.ucdavis.edu/mjguinan/apc100/modules/nervous/pns/nerve1/nerve1.html(URL no longer active)).

Typically a nerve action potential (NAP) or compound nerve actionpotential (CNAP), which is a summated potential of the action potentialsin all the axons in a nerve, as a signal travels down a nerve, is sensedusing an electrical sensor probe that detects the waveform of a voltageassociated with the NAP. Accordingly, traditional methods usedelectrical stimulation to trigger a NAP signal in a nerve. Onedisadvantage of using electrical stimulation is that the electricalsignal applied to stimulate one nerve fiber will generally stimulate aplurality of surrounding nerve fibers (even nerve fibers in otherfascicles than the fascicle containing the nerve of interest) to alsotrigger NAP signals in those other nerve fibers: Present conventionalneuromodulation technology is based on the generation of electric fieldsaround the neuron. The spatial differential voltage along the axons,commonly referred to as the driving function, results in adepolarization of the neural membrane. This depolarization results inaction-potential generation, which is then transmitted to target organwhere it produces a characteristic effect. The electric field issignificantly influenced by the electrical impedance of the tissues.

Extraneural electrodes, such as the Flat Interface Nerve Electrode(FINE), have demonstrated fascicular selectivity (to within about 400μm). The perineurium, which surrounds a plurality of nerve axons anddefines the individual fascicle, typically has a high impedance. Thiscauses the voltage distribution to be fairly uniform within at least aportion of a fascicle (while also being electrically isolated fromneighboring fascicles), hence limiting the possibility of sub-fascicularselectivity when using electrical stimulation. While the spatialselectivity of these extraneural electrodes (such as the FINE) has beensuccessfully shown to produce functional neural stimulation in clinicalapplications, neuromodulation applications such as hand-grasp,sensory-stimulation applications for artificial prostheses, and controlof autonomic functions such as cardiac rate via Vagus-nerve stimulation,require, in some cases, selection of at most one fascicle and evengreater sub-fascicular spatial selectivity (i.e., selection of a singleaxon or just a few axons but not all the axons in the single fascicle)than is typically possible using electrical stimulation alone, such thatseparate signals are delivered to different axons within one fascicle.

As a convention used herein, a nerve will be defined as a collection ofindividual nerve fibers (i.e., axons) of individual nerve cells(neurons) that together form a set of nerve pathways (an integrated setof pathways for signal propagation within the nervous system). Subsetsof the individual nerve fibers are each bundled into one of a pluralityof fascicles that together form the nerve. Action potentials can occurin the axon portion of individual nerve cells. A series of individualnerve fibers that together form an integrated signal pathway starting ata sensory-receptor nerve ending and extending to the brain will bereferred to as a sensory-nerve pathway, while a series of individualnerve fibers that together form an integrated signal pathway starting atthe brain and extending to a muscle cell will be referred to as amotor-nerve pathway. A sensory-nerve pathway that carries auditorysignals will be referred to as an auditory-nerve pathway, and asensory-nerve pathway that carries signals from the sense-of-balanceorgans (e.g., the vestibular organs of the inner ear, or perhaps theeyes) will be referred to as a sense-of-balance nerve pathway. Asensory-nerve pathway that carries olfactory signals will be referred toas an olfactory-nerve pathway, a sensory-nerve pathway that carriestaste signals will be referred to as a taste-nerve pathway, and asensory-nerve pathway that carries tactician signals will be referred toas a tactile-nerve pathway.

Within each fascicle of a nerve, there will typically be a plurality ofsensory-nerve pathways and a plurality of motor-nerve pathways, whereinthe number of sensory-nerve pathways will typically be about fifteentimes as many as the number of motor-nerve pathways. As well, a seriesof individual nerve fibers may together form an integrated pathwaystarting at one of various internal organs and ending in the brain, withthen other series of individual nerve fibers together forming anintegrated pathway starting at the brain and extending to some internalend organ (such as the digestive tract, the heart, or blood vessels) aspart of the autonomic nervous system; and a series of individual nervefibers may together form an integrated pathway within the brain referredto as a tract. As used herein, a nerve bundle or fascicle refers to acollection of nerve fibers that subserve a common or similar function(e.g., a fascicle may support a plurality of different motor-nervepathways and thus motor-control signals needed for the muscles for ahand grasp, for example; similarly the same and/or a nearby fascicle maysupport a plurality of corresponding sensory-nerve pathways and thussensory signals that provide the brain with feedback for the handgrasp).

U.S. patent application Ser. No. 12/018,185 filed Jan. 22, 2008 by MarkP. Bendett and James S. Webb, titled “Hybrid Optical-Electrical Probes”(now U.S. Pat. No. 7,883,536 issued Feb. 8, 2011, Attorney Docket No.5032.027US1), which is incorporated herein by reference in its entirety,describes an optical-signal vestibular-nerve stimulation device andmethod that provides different nerve stimulation signals to a pluralityof different vestibular nerves, including at least some of the threesemicircular canal nerves and the two otolith organ nerves. In someembodiments described in that patent application, balance conditions ofthe person are sensed by the implanted device, and based on the sensedbalance conditions, varying infrared (IR) nerve-stimulation signals aresent to a plurality of the different vestibular nerves. Also describedis a method that includes obtaining light from an optical source;transmitting the light through an optical fiber between a tissue of ananimal and an optical transducer, and detecting electrical signals usingconductors attached to the optical fiber. The application also describesan apparatus that includes an optical source, an optical transmissionmedium operatively coupled to the optical source and configured totransmit light from the optical source to respective nerves of each ofone or more organs of an animal, an electrical amplifier, and anelectrical transmission medium integral with the optical transmissionmedium and operatively coupled to the electrical amplifier, wherein theelectrical transmission medium is configured to transmit an electricalsignal from the respective nerves to the electrical amplifier.

U.S. Pat. No. 6,921,413 issued Jul. 26, 2005 to Mahadevan-Jansen et al.,titled “Methods and devices for optical stimulation of neural tissues,”and U.S. patent application Ser. No. 11/257,793 filed Oct. 24, 2005 byWebb et al. (now U.S. Pat. No. 7,736,382, which issued Jun. 15, 2010),titled “Apparatus for Optical Stimulation of Nerves and Other AnimalTissue,” are each incorporated herein by reference in their entirety.Both of these describe optical stimulation of nerves in general.

U.S. Patent Application Publication No. US 2006/0161227, of Walsh etal., titled “Apparatus and Methods for Optical Stimulation of theAuditory Nerve,” is incorporated herein by reference in its entirety.This application describes a cochlear implant placed in a cochlea of aliving subject for stimulating the auditory system of the livingsubject, where the auditory system comprises auditory neurons. In oneembodiment, the cochlear implant includes a plurality of light sources{L_(i)}, placeable distal to the cochlea, each light source beingoperable independently and adapted for generating an optical energy,E_(i), wherein i=1, . . . , N, and N is the number of the light sources,and delivering means placeable in the cochlea and optically coupled tothe plurality of light sources, {L_(i)}, such that in operation, theoptical energies {E_(i)} generated by the plurality of light sources{L_(i)} are delivered to target sites, {G_(i)}, of auditory neurons,respectively, wherein the target sites G₁ and G_(N) of auditory neuronsare substantially proximate to the apical end and the basal end of thecochlea, respectively.

U.S. Patent Application Publication No. US 2005/0004627 titled “Auditorymidbrain implant” filed by Peter Gibson et al. on Aug. 26, 2004, isincorporated herein by reference this application issued as U.S. Pat.No. 7,797,029 on Sep. 14, 2010). This application describes an electrodearray that is implantable within the inferior colliculus of the midbrainand/or other appropriate regions of the brain of an implantee andadapted to provide electrical stimulation thereto. The electrode arrayincludes an elongate member having a plurality of electrodes mountedthereon in a longitudinal array. A delivery cannula for delivering theelectrode array comprised of two half-pipes is also described.

U.S. Patent Application No. US 2007/0261127 A1 filed Jul. 24, 2006, byEdward S. Boyden and Karl Deisseroth, titled “Light-Activated CationChannel and Uses Thereof”; U.S. Patent Application No. US 2007/0054319A1 filed Jul. 24, 2006, by Edward S. Boyden and Karl Deisseroth, titled“Light-Activated Cation Channel and Uses Thereof”; and U.S. PatentApplication No. US 2007/0053996 A1 (now abandoned) filed Jul. 24, 2006,by Edward S. Boyden and Karl Deisseroth, titled “Light-Activated CationChannel and Uses Thereof” are all incorporated herein by reference.These describe compositions and methods for light-activated cationchannel proteins and their uses within cell membranes and subcellularregions. They describe proteins, nucleic acids, vectors and methods forgenetically targeted expression of light-activated cation channels tospecific cells or defined cell populations. In particular thedescriptions describe millisecond-timescale temporal control of cationchannels using moderate light intensities in cells, cell lines,transgenic animals, and humans. The descriptions provide for opticallygenerating electrical spikes in nerve cells and other excitable cellsuseful for driving neuronal networks, drug screening, and therapy.

An article authored by Han, Xue, et al. titled “Multiple-Color OpticalActivation, Silencing, and Desynchronization of Neural Activity, withSingle-Spike Temporal Resolution” (PLoS ONE 2(3): e299.doi:10.1371/journal.pone.0000299, March 2007) is incorporated herein byreference. This article describes targeting the codon-optimized form ofthe light-driven chloride pump halorhodopsin from the archaebacteriumNatronomas pharaonis (hereafter abbreviated Halo) togenetically-specified neurons enables them to be silenced reliably, andreversibly, by millisecond-timescale pulses of yellow light. The articledescribes that trains of yellow and blue light pulses can drivehigh-fidelity sequences of hyperpolarizations and depolarizations inneurons simultaneously expressing yellow light-driven Halo and bluelight-driven ChR2, allowing for the first time manipulations of neuralsynchrony without perturbation of other parameters such as spikingrates. The article further describes the Halo/ChR2 system thusconstitutes a powerful toolbox for multichannel photoinhibition andphotostimulation of virally or transgenically targeted neural circuitswithout need for exogenous chemicals, thus enabling systematic analysisand engineering of the brain, and quantitative bioengineering ofexcitable cells.

An article authored by Bernstein, Jacob G., et al. titled “Prostheticsystems for therapeutic optical activation and silencing ofgenetically-targeted neurons” (Proc Soc Photo Opt Instrum Eng.; 6854:68540H., May 5, 2008) is incorporated herein by reference. This articledescribes that the naturally-occurring light-activated proteinschannelrhodopsin-2 (ChR2) and halorhodopsin (Halo/NpHR) can, whengenetically expressed in neurons, enable them to be safely, precisely,and reversibly activated and silenced by pulses of blue and yellowlight, respectively. The article describes the ability to make specificneurons in the brain light-sensitive, using a viral approach. Thearticle also describes the design and construction of a scalable, fullyimplantable optical prosthetic capable of delivering light ofappropriate intensity and wavelength to targeted neurons at arbitrary3-D locations within the brain, enabling activation and silencing ofspecific neuron types at multiple locations. The article furtherdescribes control of neural activity in the cortex of the non-humanprimate, a key step in the translation of such technology for humanclinical use. The article asserts systems for optical targeting ofspecific neural circuit elements may enable a new generation ofhigh-precision therapies for brain disorders.

U.S. Patent Application No. US 2009/0210039 A1 filed Jan. 16, 2009, byEdward S. Boyden et al., titled “Prosthetic Systems for TherapeuticOptical Activation and Silencing of Genetically-Targeted Neurons,” isincorporated herein by reference. The application describes an opticalprosthesis that permits control of neural circuits that comprises aprobe having a set of light sources, drive circuit connections connectedto each light source, a housing surrounding the light sources and drivecircuit connections, and drive circuitry for driving and controlling theprobe. The application also describes drive circuit connections anddrive circuitry may optionally provide for wireless communication. Theapplication describes light sources may be light-emitting diodes,lasers, or other suitable sources. The application describes the devicemay optionally include sensors for monitoring the target cells. Theapplication also describes a multi-dimensional array of probes, eachprobe having a set of light sources, drive circuit connections connectedto each light source, a housing surrounding the light sources and thedrive circuit connections, drive circuitry for driving and controllingthe probes, and supporting hardware that holds the probes in positionwith respect to each other and the target cells.

There are patients suffering from incomplete spinal cord injuries thatdo not result in complete loss of movement and sensation below theinjury site. Injuries resulting from an anterior spinal cord injury thatinclude damage to the front of the spinal cord affect pain, temperature,and touch sensation, but leave some pressure and joint sensation, andwherein often motor function is unaffected.

Injuries to the central portion of the spinal cord can result in CentralCord Syndrome and form an incomplete spinal cord injury in which some ofthe signals from the brain to the body are not received, characterizedby impairment in the arms and hands and, to a lesser extent, in thelegs. In some injuries, sensory loss below the site of the spinal injuryand loss of bladder control may occur. Central Cord Syndrome, which isusually the result of trauma, is associated with damage to the largenerve fibers that carry information directly from the cerebral cortex ofthe brain to the spinal cord and these large nerves are particularlyimportant for hand and arm function. Symptoms of large nerve fiberdamage may include paralysis and/or loss of fine control of movements inthe arms and hands, with relatively less impairment of leg movements.Often, the brain's ability to send and receive signals to and from partsof the body below the site of trauma is affected but not entirelyblocked.

Spinal injuries caused by a lesion affecting the lateral half of thespinal cord is known as Brown-Séquard syndrome, and is characterized bycontralateral hemisensory anesthesia to pain and temperature,ipsilateral loss of propioception, and ipsilateral motor paralysis belowthe level of the lesion. Tactile sensation is generally spared.

The most common type of spinal cord injury is a spinal contusion whereinthe spinal cord is bruised but not severed. The spinal contusion resultsin inflammation and bleeding in the spinal column near the site of theinjury which can kill spinal cord neurons. Finally, injuries toindividual nerve cells manifest as a loss of sensory and motor functionsin the area of the body to which the injured nerve root corresponds.

Besides such spinal-cord injuries, there are numerous other nerveinjuries and pathologies that need treatment. Thus, there is a need toprovide therapy (e.g., through stimulation of physiological signals inthe patient such as nerve action potentials (NAPs)) that restores suchsensations (signals towards the brain) to persons having such injuries,as well as nerve stimulation and/or inhibition for treatment of pain,obesity, epilepsy, depression, and the like. There is also a need toprovide therapy that restores motor-nerve (muscle-control) signals fromthe brain towards muscles or prostheses (through NAP stimulation,inhibition, or both), for motor control as well as treatment ofincontinence, irregular heart rhythms, tremors or twitches, and thelike.

There is also a need for efficacious apparatus and methods for opticallystimulating, and/or optically and electrically stimulating, nerves ofthe central nervous system (CNS) and/or the peripheral nervous system(PNS) in a living animal in order to generate a nerve action potential(NAP) in one neuron (nerve cell), or in multiple neurons within a nervebundle or nerve (where the combined individual NAPs form a compoundnerve action potential, or CNAP), or similar physiological response inthe animal. Optical and/or electrical-and-optical stimulation of neuronscan provide more precision in terms of stimulating a particular nervepathway than is possible using only electrical stimulation.

BRIEF SUMMARY OF THE INVENTION

The present invention provides an apparatus and a method for optically,or optically and electrically, stimulating neurons (e.g., sensory and/ormotor neurons) in the peripheral nervous system (PNS), and or thecentral nervous system (CNS) (including the spinal cord and/or brainstemand/or midbrain and/or brain tissue of a living animal) to obtain aphysiological response in the animal (e.g., a sense of touch, taste,smell, sight or sound). In some embodiments, the simultaneousapplication of both an optical stimulation signal and an electricalstimulation signal provides more efficacious generation of NAP responsesin the animal than either optical or electrical stimulation alone. Inaddition, the much higher precision possible when using opticalstimulation permits many more channels of auditory nerve pathways to beindividually and distinctly stimulated than is possible using electricalstimulation alone. In some embodiments, the application of an electricalfield before or during the application of the optical stimulation pulsepermits more reliable generation of nerve-action-potential signals thanis possible using the optical signal pulse alone, and permits reliablegeneration of NAP signals.

One purpose of the present peripheral nervous system (PNS) and/or thecentral nervous system (CNS) optical stimulator or hybrid stimulator(wherein the hybrid stimulator uses both optical and electricalstimulation) is to provide sensory sensations and/or motor responses forpatients who have sensory neuron or motor neuron impairment. Another useof some embodiments of the present invention is to provide an apparatusand method for conducting basic and clinical research on how to improvethe performance of PNS and CNS neural implants using infrared lasertechnology, optionally also using simultaneous electrical stimulation.The optical PNS and CNS neural stimulator can also be used as a powerfulresearch tool to stimulate discrete regions and neuronal populationswithout the concerns of shock artifact, a phenomenon that is inherent toelectrical-stimulation paradigms.

In some embodiments, the present invention provides apparatus andmethods for optical stimulation or optical-and-electrical stimulation ofPNS and CNS neural pathways and/or brain tissue. In some embodiments ofthe present invention, radiant energy exposure of the PNS and CNS neuralpathways using a mid-wavelength infrared laser generatesoptically-evoked sensory and/or motor neuron responses.

In other embodiments, the present invention provides apparatus andmethods for optical stimulation or optical-and-electrical stimulation ofnerve pathways and/or brain tissue of sensory modalities. In some suchembodiments, apparatus and methods are provided for optical stimulationor optical-and-electrical stimulation of nerve pathways and/or braintissue involved in vision. In other such embodiments, apparatus andmethods are provided for optical- or optical-and-electrical stimulationof nerve pathways and/or brain tissue involved in olfaction. In othersuch embodiments, apparatus and methods are provided for optical- oroptical-and-electrical stimulation of nerve pathways and/or brain tissueinvolved in balance. In other such embodiments, apparatus and methodsare provided for optical- or optical-and-electrical stimulation of nervepathways and/or brain tissue involved in tactile sense. In other suchembodiments, apparatus and methods are provided for optical- oroptical-and-electrical stimulation of nerve pathways and/or brain tissueinvolved in taste. In other such embodiments, apparatus and methods areprovided for optical- or optical-and-electrical stimulation of nervepathways and/or brain tissue involved in hearing. In other suchembodiments, apparatus and methods are provided for optical- oroptical-and-electrical stimulation of nerve pathways and/or brain tissueinvolved in proprioception. In other such embodiments, apparatus andmethods are provided for optical- or optical-and-electrical stimulationof nerve pathways and/or brain tissue involved in temperature. In othersuch embodiments, apparatus and methods are provided for optical- oroptical-and-electrical stimulation of nerve pathways and/or brain tissueinvolved in pain management. In some embodiments, apparatus and methodsare provided for optical- or optical-and-electrical stimulation ofcombinations of two or more of the above-mentioned sensations.

In some embodiments, one or more of the apparatus as described in therelated provisional patent applications, patent applications and/orpatents incorporated by reference above (e.g., 60/715,884, 60/826,538,60/872,930, 60/884,619, 60/885,879, 60/964,634, 61/015,665, 61/102,811,61/147,073, Ser. Nos. 11/257,793, 11/536,639, 11/948,912, 11/536,642,11/971,874, 12/018,185, 12/191,301, 12/573,848, and 12/693,427) are usedto generate and/or deliver the optical-stimulation signals andoptionally the electrical-stimulation signals that are delivered to thePNS and/or the CNS of the patient using methods and apparatus of thepresent invention. In some embodiments, the method of the presentinvention includes emitting a trigger amount of pulsed light and furtherincludes applying a precharge current of electrical energy that isfollowed by the trigger amount of pulsed light intensity of theplurality of light signals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic diagram 101 of a nerve 11.

FIG. 1B is a schematic diagram 102 of a nerve 11.

FIG. 2A is a block diagram of an implantable/partially implantablesystem 201.

FIG. 2B is a block diagram of a wireless-transmission partiallyimplantable system 202.

FIG. 2C is a schematic side view of implantable fiber-optic bundle 253with optional electrical conductors.

FIG. 2D is a schematic end view of implantable fiber-optic bundle 253with optional electrical conductors.

FIG. 2E is a schematic side view of an embodiment of optical fiber 238from the implantable fiber-optic bundle device 253 of FIG. 2C in animplanted configuration 250.

FIG. 2F is a schematic side view of an embodiment of optical fiber 238from the implantable fiber-optic bundle device 253 of FIG. 2C in animplanted configuration 251.

FIG. 2G is a schematic side view of an embodiment of optical fiber 248in an implanted configuration 252.

FIG. 2H is a schematic side view of an embodiment of an implantablefiber-optic bundle 258.

FIG. 3 is a schematic block diagram of nerve stimulator 301, accordingto some embodiments of the present invention.

FIG. 4 is a schematic representation of a plurality of light-deliveryoptions 401 from fiber optics/waveguides.

FIG. 5 is a schematic representation of a plurality of nerve stimulatorlight delivery options 501, according to some embodiments of the presentinvention.

FIG. 6A is a cross-section end-view schematic representation of acircular cuff nerve stimulator 601, according to some embodiments of thepresent invention.

FIG. 6B is a side-view schematic representation of a circular cuff nervestimulator 602, including control electronics, according to someembodiments of the present invention.

FIG. 7A is a cross-section end-view schematic representation of amultiple-wavelength nerve stimulator 701, according to some embodimentsof the present invention.

FIG. 7B is a side-view schematic representation of a multiple-wavelengthnerve stimulator 702, according to some embodiments of the presentinvention.

FIG. 7C is a cross-section end-view schematic representation of amultiple-focal-length nerve stimulator 703, according to someembodiments of the present invention.

FIGS. 7D1, 7D2, and 7D3 are cross-section end-view schematicrepresentations of a multiple-intersection nerve stimulator 704,according to some embodiments of the present invention.

FIG. 8 is a cross-section end-view schematic representation of atransversely-implanted nerve stimulator 801, according to someembodiments of the present invention.

FIG. 9A is a block diagram of a computerized system 901 for determininga reaction of the nerve tissue through empirical testing of thelight-emitting structure, power levels and/or electricalpreconditioning.

FIG. 9B is a block diagram of a computerized method 902 for determininga reaction of the nerve tissue through empirical testing of thelight-emitting structure, power levels and/or electricalpreconditioning, and then using the mapping obtained from the testing tocontrol a nerve stimulator.

DETAILED DESCRIPTION OF THE INVENTION

Although the following detailed description contains many specifics forthe purpose of illustration, a person of ordinary skill in the art willappreciate that many variations and alterations to the following detailsare within the scope of the invention. Accordingly, the followingpreferred embodiments of the invention are set forth without any loss ofgenerality to, and without imposing limitations upon, the claimedinvention. Further, in the following detailed description of thepreferred embodiments, reference is made to the accompanying drawingsthat form a part hereof, and in which are shown by way of illustrationspecific embodiments in which the invention may be practiced. It isunderstood that other embodiments may be utilized and structural changesmay be made without departing from the scope of the present invention.

The leading digit(s) of reference numbers appearing in the Figuresgenerally corresponds to the Figure number in which that component isfirst introduced, such that the same reference number is used throughoutto refer to an identical component which appears in multiple Figures.Signals and connections may be referred to by the same reference numberor label, and the actual meaning will be clear from its use in thecontext of the description.

Applying an electrical signal across or into a neuron (nerve cell), or anerve bundle or nerve, is one way to stimulate a nerve action potential(NAP), either in a single neuron (nerve cell), or in a plurality ofneurons within a nerve bundle, or within a nerve (the combined signalsof NAPs in a nerve bundle or nerve are referred to as a compound nerveaction potential (CNAP)). Applying an optical signal (e.g., a shortrelatively high-power pulse of infrared (IR) laser light, in someembodiments, for example at a signal wavelength about 1.9 microns, asignal wavelength of including the range of about 1.8 microns and about2 microns, or a signal wavelength of including the range of about 1.6microns and about 1.8 microns or a signal wavelength of including therange of about 1.4 microns and about 1.6 microns, while in otherembodiments, between about 0.2 microns and about 3 microns, inclusive)is another way to stimulate a NAP.

In some embodiments, the present invention provides methods andapparatus for stimulating nerves, fascicles, and individual nerve fibersin the PNS and CNS, including cranial nerves. In some embodiments, themethods and apparatus described herein are capable of being configuredto stimulate a single nerve, a single fascicle, a single nerve fiber,multiple nerves, multiple fascicles, multiple nerve fibers or acombination of one or more nerves, and/or one or more fascicles, and/orone or more nerve fibers. As used herein, a method or apparatus that isdescribed as being capable of stimulating a nerve is also capable ofproviding stimulation of fascicles and nerve fibers or a combination ofnerve(s), and/or fascicle(s), and/or nerve fiber(s).

In some embodiments, the present invention provides permutations forpractical implementation of implantable light-neural interfaces inperipheral and cranial nerves for stimulating sensory or motor functionas needed for a given application. In some embodiments, neuralprosthetic devices are artificial extensions of the body that restore orsupplement nervous system function that were lost due to disease orinjury. The current worldwide market for neural prostheses and similarneuromodulation devices is estimated to be over $3 billion, and roughly⅓ to ½ of which involves interaction with peripheral and cranial nerves.Previous and current conventional devices use electrical stimulation(ES) to interface with the nervous system, which leads to numerousissues. Because electrical current spreads in the body, most if not allES-based neural prostheses wind up stimulating other nerves in the areabesides the intended target (e.g. fine movements cannot be made with amotor prosthesis, and multiple sensations, such as touch andtemperature, may be felt incorrectly from a sensory feedback device).Furthermore, the presence of a stimulation artifact can obfuscatesignals elsewhere along the nerve, and it also precludes stimulating andrecording electrical nerve activity in the same location, as needed fora closed-loop sensorimotor limb prosthesis. Thus, all of the numerousES-based neural interfaces have fundamental shortcomings that limittheir ability to seamlessly integrate with the human body.

Infrared Neural Stimulation (INS) has the potential to significantlyimprove neural prostheses and neuromodulation devices and INS hasimproved selectivity over ES because light is directed in a singledirection; and thus INS has no stimulation artifact, which allows forstimulation and recording of nerve activity in the same location.Importantly, the various materials available for these INS implantabledesigns can be safer and more biocompatible than current ES devices.Thus, these INS implantable interface designs are key to the developmentof more precise, biofidelic neural devices to meet a very large, growingworldwide demand.

In some embodiments, the disclosed designs for interfacing light(infrared for INS or other wavelengths, typically visible, for“photostimulation”) with peripheral, cranial, or central nerves can bebroken down into two major subgroups. A first group of designs usedirect light output of vertical-cavity surface-emitting lasers (VCSELs)to stimulate nerves, with VCSELs being placed either outside the nerve(“non-invasive”), just inside the epineurium, which is the outermostcovering of the nerve (“minimally invasive”), or placed amongst theindividual fascicles inside the nerve (“invasive”). Another group ofdesigns uses light being delivered from either a VCSEL or other laservia a number of very different waveguide designs in non-invasive,minimally invasive, or invasive approaches as defined above.

In some embodiments, these INS implantable devices have controlelectronics to drive them to elicit the appropriate physiologicalresponse (e.g. motor function, sensory inputs, and the like) bystimulating a peripheral, central, or cranial nerve. In someembodiments, the present invention provides practical interface designsfor the implantable devices to effectively utilize the presentinvention.

The present invention uses a light-propagating transmission medium tocarry optical signals between a light source and the tissue (e.g.,neurons) of the patient, in order to stimulate a nerve action potential.In some embodiments, the transmission medium includes one or moreoptical fibers (e.g., a bundle of optical fibers, each of which includesa waveguide (e.g., the core of the fiber, which has a higher index ofrefraction than the cladding). In some embodiments, thelight-propagating medium includes a plurality of side-by-sidelongitudinal (parallel-like) waveguides formed in an optical fiber oroptical “ribbon.” In some embodiments, a planar substrate is used,wherein the planar substrate includes a plurality of waveguides, andoptionally includes other optical components such as filters, evanescentcouplers, optical-fiber interfaces, selective gates that control theamplitude of light output, focusing elements, light-output ports (e.g.,gratings that allow light to exit the waveguides toward the tissues ofinterest) and the like. In some embodiments, a tapered silicon substrate(or other light-transmitting material such as: ZnSe, InP, fused silica,quartz, and the like) is used, the substrate having a plurality ofwaveguides formed by three-dimensional (3D) etching at the light-outputtip (and optionally also at an input interface that receives light(e.g., from a plurality of optical fibers). In some embodiments, theoutput end of such an optical element is called a “probe” and allows alarge number of light-output ports, such that after implantationadjacent to the brainstem or midbrain of the patient, individual ones ofthe output ports are individually activatable to determine which portsstimulate which nerve pathways. A mapping of which port is couplinglight to which nerve pathway is then programmed into the controller thatdrives a particular optical signal to the desired nerve pathway to bestimulated. Because there are many more light-output ports than nervedestinations, the implanted device can be programmed to send theappropriate signals to each of a plurality of nerve pathways, greatlysimplifying placement of the output probe (as compared to having toindividually place each of a plurality of separate fibers). Further, ata later time, the implanted device can be recalibrated, remapped andreprogrammed to compensate for movement of the probe relative to thetissue to be stimulated. In addition, refinements based onlater-discovered principles can be reprogrammed into the implanteddevice to provide a better sense of hearing for audio implants. Ofcourse, other embodiments include implanted devices that provide othersensations, such as vision, olfaction, touch (some embodiments includingsexual sensations), temperature, pressure, and the like.

In some embodiments, the light signal used to stimulate a nerve actionpotential includes wavelengths in the range of 1800 nm to 2100 nm. Inother embodiments, the stimulation light signal includes wavelengths inthe range of 1400 nm to 1500 nm, the range of 1500 nm to 1600 nm, orother suitable light wavelength in the range of 300 nm to 10,000 nm.

FIG. 2A is a block diagram of an implantable or partially implantablesystem 201 (according to some embodiments of the present invention) thatuses a VCSEL (vertical-cavity surface-emitting laser) array for lightstimulation of neuronal tissue 99 in the brainstem and/or midbrainnerves such as the auditory brainstem to obtain an auditory brainstemresponse (ABR) (e.g., some embodiments use a VCSEL array such asdescribed by U.S. Provisional Patent Application No. 60/964,634 filedAug. 13, 2007, titled “VCSEL Array Stimulator Apparatus and Method forLight Stimulation of Bodily Tissues,” which is incorporated herein byreference in its entirety). System 201 represents one embodiment of thepresent invention, wherein a low-power, low-threshold VCSEL array 205emits laser light from each of a plurality of VCSELs, for example VCSELsimplemented as an array of separately activatable lasers formed in amonolithic semiconductor chip. Each laser beam is separately controlledby controller signals 218 from laser-and-power controller 210 undercontrol of a stimulation-calculation processor or circuitry 209.Controller signals 218 drive the laser-diode VCSELs that generate lightsignals 211 that are configured to stimulate the tissue as desired. Forexample, in some embodiments, the light signals 211 are collimated,focused and/or guided by optics 203 within device enclosure 204 intodelivery medium 207 (e.g., a bundle of optical fibers), which extendsfrom the enclosure 204 to a remote location such as in the brainstem ormidbrain 99 of patient 98. In some embodiments, the system also uses avisible laser and/or LED (light-emitting diode) array 206 that producevisible light signals 212 to help align the VCSEL laser array signals211 with the lens array/beam coupler/combiner optics 203, and/or toindicate where the IR signals are being emitted from the far end ofdelivery medium 207 to help the surgeon align the distal tip of thedelivery medium 207 to the appropriate neuronal tissue during theimplantation procedure. In some embodiments, one or more sensors 208 areused to obtain audio information, balance or orientation information,temperature information, or other information that is to be converted tonerve-stimulation signals (e.g., optical signals and optionally alsoelectrical signals) to deliver to patient 98 through the patient'sbrainstem or midbrain neurons 99. In some embodiments, the sensors 208are implanted inside the patient 98. In other embodiments (such asdescribed below for FIG. 2B), one or more sensors are part of anexternal unit 220 that is wirelessly coupled to the implanted device202.

In some such embodiments, implantable/partially implantable system 201includes rechargeable batteries to provide power to the stimulator. Insome such embodiments, power is provided to the system 201 from outsideof the body using wireless charging (e.g., in some embodiments,inductive battery charging) such that the batteries can be rechargedwithout the need to perform surgery to gain access to the stimulator.

In some embodiments, electrical nerve-stimulation signals 219 aregenerated by stimulation-calculation processor or circuitry 209, and aredelivered to the stimulation site using delivery medium 207 (e.g., abundle having one or more electrical conductors and one or more opticalfibers), such as described in U.S. patent application Ser. No.12/018,185 filed Jan. 22, 2008, titled “Hybrid Optical-ElectricalProbes” (now U.S. Pat. No. 7,883,536 issued Feb. 8, 2011, AttorneyDocket No. 5032.027US1); U.S. patent application Ser. No. 12/191,301filed Aug. 13, 2008, titled “VCSEL Array Stimulator Apparatus and Methodfor Light Stimulation of Bodily Tissues” (Attorney Docket No.5032.038US1), and U.S. patent application Ser. No. 12/573,848 filed Oct.5, 2009, titled “Nerve Stimulator and Method using SimultaneousElectrical and Optical Signals” (Attorney Docket No. 5032.045US1); eachof which is incorporated herein by reference in its entirety. In otherembodiments, optical-only stimulation is used, and thus no electricalstimulation is used in such embodiments.

In some embodiments, the electrical signals 219 are used to sensitizethe neuronal tissue (as opposed to being sufficient to trigger a nerveaction potential using only the electrical signal) in order that alower-power optical stimulation signal is sufficient to trigger thedesired nerve action potential (NAP) in one or more neurons in thebrainstem or midbrain of the patient, the spinal cord or other nerves.

In some embodiments, the optical (and optional electrical) signals aredelivered and directed upon the auditory brainstem nerves, i.e., CranialNerve VIII (the cranial nerve for hearing and balance), or otherbrainstem or midbrain tissue 99 of a patient 98. In some embodiments,some or all of system 201 is implanted within patient 98. In someembodiments, the end of delivery medium 207 that is distal to beamcombiner 203 includes a plurality of optical fibers that are configuredto output light in a plurality of different locations and/or differentdirections from a single location. In some embodiments, delivery medium207 also includes a plurality of electrical conductors that areconfigured to output electrical signals in a plurality of differentlocations (e.g., to one or more of those locations at any one time)and/or different directions (e.g., to one or more of those directions atany one time) from a single location. In some embodiments, theelectrical signals are used to precondition the neurons to be stimulatedsuch that a lower-intensity optical signal can be used to trigger thedesired nerve-action-potential pulse.

In some embodiments, the optical (and optional electrical) signals aredelivered and directed upon other brainstem nerves, for instance,Cranial Nerve II (the cranial nerve for vision), Cranial Nerve I (thecranial nerve for olfaction), or the like. In some such embodiments,suitable external sensors 208 for the necessary input data(environmental parameters) from the environment (such as, for example,microphones, pressure sensors, vibration sensors, gyroscopes,accelerometers, gravity-direction sensors, electromagnetic-radiationsensors such as imaging devices, light sensors and color sensors,chemical sensors (i.e., for odors and/or taste), and the like;collectively called environmental sensors, which generate environmentalsignals and/or environmental data, based on the environmentalparameter(s), which are to be analyzed and used to control nervestimulators).

In some embodiments, one or more pressure, texture, vibration, weightand/or similar sensors are used to obtain touch-and-feel data from theenvironment, this touch-and-feel data is processed to detectmechanical-touch aspects of an object, and the processedmechanical-touch data is used to generate stimulation signals used todrive optical and/or electrical probes that therapeutically stimulatethe midbrain or brainstem portion of other nerve pathways in order toprovide a simulated touch-and-feel sensation for the patient.

In some embodiments, one or more balance, acceleration, rotation and/orsimilar environmental sensors as used to sense the position and movementof the patient's body within its environment, and the resulting signalsare used to therapeutically stimulate nerves to correct balance ormovement problems.

Further, in some embodiments, one or more nerve-action-potential (NAP)sensors are used to obtain nerve-and-movement-disorder data, thisnerve-and-movement-disorder data is processed to detect nerve-signalpatterns that are indicative of Parkinson's Disease or other movementdisorders, and the processed nerve-signal data is used to generatestimulation signals used to drive optical and/or electrical probes thatstimulate the midbrain or brainstem portions (such as the red nucleusand substantia nigra) of affected nerve pathways in order to treat orinhibit the movement disorder of the patient. In some embodiments, suchNAP sensors and/or other patient-physiology sensors (such asmuscle-contraction sensors, EKG (electrocardiogram) sensors, EEG(electroencephalogram) sensors, temperature sensors, stomach-acidsensors and the like) are used to generate patient-physiology signalsand/or patient-physiology data to be analyzed and used to control nervestimulators.

Still further, in some embodiments, an imaging device is used as asensor 208 (or as part of an external sensor-transmitter 220 asdescribed below for FIG. 2B) to obtain image data, this image data isprocessed to detect vision aspects of the image data such as patterns(e.g., vertical objects, horizontal objects, diagonal objects, curvedobjects and the like), color (e.g., hue, saturation, brightness,contrast and the like with regard to various objects and patterns),motion (direction, speed, enlargement, and the like) and the processedimage data is used to generate stimulation signals used to drive opticaland/or electrical probes that stimulate the midbrain or brainstemportion of Cranial Nerve II (the cranial nerve for vision) in order toprovide a simulated vision sensation for the patient. In someembodiments, electromagnetic-radiation sensors that do not generateimage data as such, for example light sensors and color sensors, areused to obtain more generic electromagnetic-radiation data from theenvironment (such as the color of an object), and this genericelectromagnetic-radiation data is processed to provide and controloptical- and/or electrical-stimulation signals that stimulate themidbrain or brainstem portion of Cranial Nerve II to provide morefundamental sensations (such as the color of whatever the color sensoris aimed at).

Even further still, in some embodiments, one or more chemical sensorsare used to obtain chemical data from the environment (e.g., datarelating to gasses or particulates from the atmosphere, or materialssuch as salts, sugars and the like dissolved in a liquid), this chemicaldata is processed to detect odor aspects of the chemical data, and theprocessed odor data is used to generate stimulation signals used todrive optical and/or electrical probes that stimulate the midbrain orbrainstem portion of Cranial Nerve I (the cranial nerve for olfaction)in order to provide a simulated smell and/or taste sensation for thepatient.

In some embodiments, and as used herein and as used in the attachedFigures and graphs, 100% power is 5 watts, and this delivers a pulseenergy of 5 mJ in a 1-ms pulse. Thus, in FIG. 2A, a 100% power level (5watts) delivered in 3-ms pulses is delivering 15 mJ per pulse, an 80%power level (4 watts) delivered in 3-ms pulses is delivering 12 mJ perpulse, a 60% power level (3 watts) delivered in 3-ms pulses isdelivering 9 mJ per pulse, a 40% power level (2 watts) delivered in 3-mspulses is delivering 6 mJ per pulse, and a 20% power level (1 watt)delivered in 3-ms pulses is delivering 3 mJ per pulse. Thus, 100% of 5watts in a 3-millisecond pulse delivers 15 mJ per pulse energy.Similarly, in FIG. 2B, 80% of the 5-W power (i.e., 4 watts) in a 0.75-mspulse delivers 3.0 mJ per pulse. In some embodiments, less than one wattof optical power is used, (e.g., in some embodiments, in a range of 100mW to 999 mW) and pulse durations in the range of about 10 microsecondsto 10,000 microseconds (10 ms) are used, resulting in pulse energies ina range of about one micro joule to about 9.99 milli joules). In otherembodiments, other amounts of optical power and/or energy are used.

In some embodiments, long-wavelength VCSEL devices and/or VCSEL arrays,such as described in U.S. Pat. No. 7,031,363 and U.S. Pat. No. 7,004,645(which are each incorporated herein by reference), are used for theVCSEL array 205.

With VCSEL emitters as small as about ten (10) microns (or smaller) indiameter per channel, in some embodiments, a single VCSEL chip orassembly is used to output multiple independent stimulation channels(VCSEL laser signals) in any array permutation or shape, and in someembodiments, these channels are fiber coupled, and/or direct lightdirectly, to a plurality of areas of tissue. In some embodiments, acombination of both fiber-coupled and direct-propagation laser output isused to stimulate tissue.

FIG. 2B is a block diagram of a wireless-transmission partiallyimplantable system 202 that uses a VCSEL array for light stimulation ofPNS, CNS, and/or brainstem and/or midbrain neurons and/or organs 99. Insome embodiments, system 202 is substantially similar to system 201described above, except that one or more external sensors, computerprocessing devices and wireless-transmitter circuitry 220 replace orsupplement one or more of the sensors 208. For example, in someembodiments, the external sensors include a pressure sensor, a processorthat converts the measured pressure into information that is wirelesslytransmitted (for example using radio waves or other suitable means) toan implanted receiver, wherein the transmitted information is useful forgenerating optical (and optionally electrical) pulses that are used tostimulate neurons 99 of patient 98. In some embodiments, system 202represents one embodiment of the present invention wherein a low-power,low-threshold VCSEL array 224 emits laser light from each of a pluralityof VCSELs, for example VCSELs implemented as an array of separatelyactivatable lasers formed in a monolithic semiconductor chip. Each laserbeam is separately controlled by laser-and-power controller 222 thatdrives controller signals 226 to the set of laser-diode VCSELs 224,which together are configured to stimulate the tissue as desired. Forexample, in some embodiments, the light signals are collimated, focusedand/or guided by optics into delivery medium 228 (e.g., a bundle ofoptical fibers). In some embodiments, the system also uses a visiblelaser and/or LED array (such as array 206 described above) that producevisible light signals to help align the VCSEL laser array signals withthe lens array/beam coupler/combiner optics. In some embodiments,electrical-stimulation or -preconditioning signals are also applied tothe tissue 99 in combination with the optical stimulation signals inorder to reduce the optical power needed to obtain a NAP.

In some embodiments, cable 226 carries both electrical power and controlsignals. In some embodiments, the electrical control signals in cable226 are multiplexed to reduce the number of wires and/or size of thecable connecting the control electronics 222 to the VCSEL-drivercircuit(s) 224 (which, in some embodiments, also includeelectrical-stimulation signal drivers to drive electrical-stimulation or-preconditioning signals that are optionally also applied to the tissue99 in combination with the optical stimulation signals). In someembodiments, the electrical control signals in cable 226 aretime-division multiplexed or serially multiplexed. In some embodiments,the electrical signals in cable 226 are multiplexed through encoding. Insome other embodiments, other commonly known methods of multiplexing areuse to reduce the number of wires and/or size of the cable connectingthe control electronics to the VCSEL driver circuit 224. In some suchembodiments, VCSEL-driver circuit 224 includes a de-multiplexor and/ordecoder that uses the information in signals from cable 226 to activateselected ones of the VCSELs at the appropriate times to trigger thedesired response, and optionally to activate associated preconditioningelectrical signals to sensitization electrodes in the vicinity of tissue99. This provides an implantable MUX-DMUX (multiplexer/demultiplexer)capability, that implements a level of ‘smarts’ and/or programmabilityin the implanted device 202 to simplify the interface 226 between theVCSEL/driver package 224 to the rest of the neurostimulator system 222(which includes a battery, software processing, telemetry, etc).

FIG. 2C is a schematic side view and FIG. 2D is a schematic end view,respectively, of an implantable fiber-optic bundle device 253 withoptional electrical conductors 236 and 237. In some embodiments,implantable fiber-optic bundle 253 includes a plurality of radiallypositioned fiber-optic cables (e.g., a bundle of optical fibers around acentral axis) 232, 233, 234 and 238. In some embodiments, a first set ortier (i.e., an innermost bundle) of optical fibers 232 are arrangedradially around a central axis and terminates using angled facets (i.e.,angled to direct light in a plurality of different outward angles fromthe central axis of the bundle of fibers) at the distal end offiber-optic device 253. The angled facets are configured to each directlight from one or more core regions within each fiber 232 at a differentradial (or radial-and-longitudinal) direction than the light coming fromother fibers 232. In some embodiments, each fiber is configured to emitlight outward from one end of the central axis of fiber-optic device 253such that a different unique or limited set of one or more nerve fibersis stimulated by optical pulses emitted from each one of the angled endfacets of the respective fibers. In some embodiments, device 253 isoriented such that the central axis of device 253 is substantiallyparallel to the length direction of the nerve bundle that is to bestimulated.

In some embodiments, common electrode 236 of FIG. 2C uses the bundle ofoptical fibers 238 to provide electrical insulation such thatlongitudinal electric fields are generated between the exposed end ofwire 236 and the ends of one or more individual wires that have theirexposed end electrodes 237 activated one or more at a time such that avoltage is applied between the end of wire 236 and the end ofelectrode(s) 237.

In some embodiments, the device 253 is implanted into a patient 98, andoptical pulses are sent out one fiber at a time in order to identifywhich fiber evokes which sensation or response (such as the perceptionof a particular frequency caused by nerve pulses of a particular nerve,nerve axon, or the like). Once it has been determined which opticalfiber evokes which response or sensation, the electronics portion 231 isconfigured or its software is programmed to send pulses at a calculatedrate to cause the patient to sense the desired sensation (e.g., in someembodiments, to “hear” a voice having a complex mix of frequencies andintensities, the patient must receive nerve pulses (compound nerveaction potentials, or CNAPs) at certain rates from certain nervepathways, and device 253 would transmit optical signals (or acombination of optical and electrical signals) to cause the particularset of nerves to experience the CNAPs necessary for that “hearing” (orother sensation), which, for example, could be based on processing amicrophone-received audio signal and generating a corresponding set ofoptical pulses at given repetition rates that are delivered through aselected set of optical fibers).

In some embodiments, a second set or tier of optical fibers 233 arearranged around the central axis radially further out and around theouter circumference of fiber-optical fibers 232, and each optical fiber233 terminates using an outward-angled facet spaced at a short distance(leftward in FIG. 2C), e.g., at 500 microns (0.5 mm), 1 mm, 1.5 mm, 2 mmor other suitable distance from the distal end (the right-hand end inFIG. 2C) of fiber-optic bundle 253. In some embodiments, a third set ortier of optical fibers 234 are arranged around the central axis andradially further out and around the outer circumference of opticalfibers 232 and optical fibers 233, and each optical fiber 234 terminatesusing an outward-angled facet spaced at a short distance (furtherleftward in FIG. 2C), e.g., at 1000 microns (1 mm), 1.5 mm, 2 mm, 2.5mm, 3 mm or other suitable distance from the distal end (the right-handend in FIG. 2C) of the fiber-optic bundle of device 253. In someembodiments, yet another set of optical fibers 238 are arranged aroundthe central axis and optical fibers 232, optical fibers 233 and opticalfibers 234 (i.e., optical fibers 238 surround optical fibers 234,optical fibers 234 surround optical fibers 233, optical fibers 233surround optical fibers 232 and optical fibers 232 are arranged radiallyaround the central axis). In some embodiments, each optical fiber 238terminates using an outward-angled facet spaced at a short distance(still further leftward in FIG. 2C), e.g., at 1500 microns (1.5 mm), 2mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm or other suitable distance from thedistal end (the right-hand end in FIG. 2C) of the fiber-optic bundle ofdevice 253. Thus, in some embodiments, the ends of the fiber-opticcables 234 extend a distance beyond the ends of fiber-optic cables 238,the ends of the fiber-optic cables 233 extend a distance beyond the endsof fiber-optic cables 234 and the ends of the fiber-optic cables 232extend a distance beyond the ends of fiber-optic cables 233 such thatlight emitted by each faceted end is not obstructed by surroundingfiber-optic cables and reaches a different portion of nerve tissue.

In some embodiments, the plurality of optical fibers 232, 233, 234 and238 include faceted ends (e.g., cleaved or polished ends), wherein theface or facet of each faceted end of the plurality of optical fibers232, 233, 234 and 238 points in a different radially-outward andlongitudinally angled direction with respect to the central axis suchthat light emitted from each faceted end (e.g., 235 and 239) travels ina direction that is at least partially radially outward from the centralaxis and intersects a different nerve or set of nerve pathways.

In some embodiments, fiber-optic bundle 253 includes a plurality ofelectrical conductors 236 and 237. In some embodiments, one or more ofthe electrical conductors include a central conducting core (e.g., abio-compatible metal or alloy) surrounded by an insulating material(e.g., a bio-compatible polymer, glass, enamel or other suitableinsulator. In some embodiments, electrical conductor 236 is a singleinsulated wire with an exposed end electrode (e.g., bare wire coated orplated with a bio-compatible electrically conductive surface) that isused as a common conductor for a plurality of other individuallyselectable electrodes 237 (i.e., a voltage is applied to the commonelectrode 236 and one of the selectable electrodes 327), and that is, insome embodiments, arranged at the central axis of the plurality offiber-optic cables 232, 233, 234 and 238 and the end of electricalconductor 236 is flush with or extends a short distance (e.g., in someembodiments, 500, 1000, or 1500 microns) beyond the end of fiber-opticcables 232. In some embodiments, electrical conductors 237 include aplurality of insulated wires (or metallic-coated optical fibers or thelike) arranged radially around or within the outer plurality offiber-optic cables 238 and the exposed end electrodes (e.g., in someembodiments, also bare wire coated or plated with a bio-compatibleelectrically conductive surface) of the electrical conductors 237 arearranged such that fiber-optic cables 238 are co-terminus or extend pastthe ends of the electrical conductors 237. In other embodiments, ratherthan using a single common electrode 236, selected pairs of electrodes237 have voltages applied, such that either a longitudinal voltage, acircumferential voltage or both a longitudinal and circumferentialvoltage is applied through the surrounding tissues of the patient. Insome embodiments, controller 231 generates signals or electrical currentflows from one electrical conductor of the plurality of electricalconductors 237 to a second and different electrical conductor of theplurality of electrical conductors 237 (i.e., in a direction tangent tothe optical-fiber bundle). In some embodiments, electrical current flowsfrom one or more electrical conductors of the plurality of electricalconductors to the single electrical conductor 236 (i.e., in alongitudinal direction relative to the optical-fiber bundle or relativeto one side of the optical-fiber bundle of device 203). In someembodiments, the electrical conductors are formed as a conducting layer(e.g., a metallization layer) that is deposited directly on each of oneor more of the optical fibers 238, 234, and/or 233, and then covered(except at an exposed conductive probe (e.g., near the tip of theoptical fiber) with one or more insulating layers (e.g., hybridelectro-optic fibers such as described in U.S. patent application Ser.No. 12/018,185 filed Jan. 22, 2008, titled “Hybrid Optical-ElectricalProbes” (now U.S. Pat. No. 7,883,536 issued Feb. 8, 2011, AttorneyDocket No. 5032.027US1), which is incorporated herein by reference).

FIG. 2E is a schematic side view of an optical fiber 238 from theimplantable fiber-optic bundle device 253 of FIG. 2C in an implantedconfiguration 250. In some embodiments, the index of refraction of fiber238 (labeled in the figures as N_(F)) is greater than the index ofrefraction of the tissue (labeled in the figures as N_(T)) in whichdevice 253 is implanted and thus the light 235 emitted from the facetedend of fiber 238 travels in a first radial direction away from thecentral axis of fiber 238.

FIG. 2F is a schematic side view of an optical fiber 238 from theimplantable fiber-optic bundle device 253 of FIG. 2C in an implantedconfiguration 251. In some embodiments, the index of refraction of fiber238 (N_(F)) is less than the index of refraction of the tissue (N_(T))in which device 253 is implanted and thus the light 235 emitted from thefaceted end of fiber 238 travels in a second radial direction away fromthe central axis of fiber 238.

FIG. 2G is a schematic side view of an optical fiber 248 in an implantedconfiguration 252. In some embodiments, fiber 248 is substantiallysimilar to fiber 238 except that the faceted end 256 of fiber 248reflects or diffracts light 235 out of fiber 248 through a window 255 ina radial or side (“side firing”) direction of the fiber 248 (see, forexample, waveguide 411 of FIG. 4).

FIG. 2H is a schematic side view of an implantable fiber-optic bundle258. In some embodiments, a single common electrode 236 has a series ofinsulated segments 236F, 236D, and 236B alternating with exposedelectrically conductive electrodes 236E, 236C, and 236A along a singlewire. The common electrode 236 of FIG. 2H (as well as the commonelectrode 236 of FIG. 2C, which uses the bundle of optical fibers toprovide electrical insulation such that longitudinal electric fields aregenerated between the exposed end of wire 236 of that implementation andthe ends of one or more individual wires that have their exposed endelectrodes activated one or more at a time such that a voltage isapplied between the end of wire 236 and the end of electrodes 237) isimplemented in a central portion of the bundle in some embodiments,while in other embodiments, the common electrode 236 is not in thecenter. In some embodiments, one of the electrodes 237 and the commonelectrode 236 have voltages applied, such that a longitudinal voltage, acircumferential voltage or both a longitudinal and circumferentialvoltage is applied through the surrounding tissues of the patient. Forexample, applying a voltage pulse that is positive on wire 237A relativeto the common electrode 236 will apply longitudinal voltages through thetissue between electrode 237A and the exposed electrodes 236E and 236C(depending on the pulse polarity applied to the wires involved, thisproduces left-to-right voltage polarity (−V1+) relative to the figure inone case and right-to-left (+V1−) in the other case). In some suchembodiments, an optical pulse at location A is emitted from theappropriate optical fiber to trigger an action potential in the tissuethat is pre- or simultaneously conditioned with the (−V1+) electricalpulse between exposed electrodes 236E and 237A, while no actionpotential is triggered in the tissue that is pre- or simultaneouslyconditioned with the (+V1−) electrical pulse between exposed electrodes237A and 236C. In some embodiments, if the response in the tissue isaffected by the longitudinal direction of the voltage, the polarity ofthe pulse is adjusted to achieve the desired action potential responsein the tissue when the associated optical pulse is applied. In some suchembodiments, an optical pulse at location B is emitted from theappropriate optical fiber to trigger an action potential in the tissuethat is pre- or simultaneously conditioned with the (+V1−) electricalpulse between exposed electrodes 237A and 236C, while no actionpotential is triggered in the tissue that is pre- or simultaneouslyconditioned with the (+V1−) electrical pulse between exposed electrodes237A and 236E.

Likewise, an optical pulse at location C is emitted from the appropriateoptical fiber to trigger an action potential in the tissue that is pre-or simultaneously conditioned with the (−V2+) electrical pulse betweenexposed electrodes 236C and 237B, while no action potential is triggeredin the tissue that is pre- or simultaneously conditioned with the (+V2−)electrical pulse between exposed electrodes 237B and 236A. Likewise, anoptical pulse at location D is emitted from the appropriate opticalfiber to trigger an action potential in the tissue that is pre- orsimultaneously conditioned with the (+V2−) electrical pulse betweenexposed electrodes 237A and 236C, while no action potential is triggeredin the tissue that is pre- or simultaneously conditioned with the (−V2+)electrical pulse between exposed electrodes 237B and 236C.

In some embodiments, a plurality of common electrodes 236 are used, eachwith alternating insulated segments 236F, 236D, and 236B alternatingwith exposed electrically conductive electrodes 236E, 236C, and 236A. Inother embodiments, selected pairs of electrodes 237 have voltagesapplied (e.g., electrodes 237A and 237B), such that either alongitudinal voltage, a circumferential voltage or both a longitudinaland circumferential voltage is applied through the surrounding tissuesof the patient.

In some embodiments, a combination of electrical signal(s) and opticalsignal(s) is used to generate the desired response (e.g., a CNAP in eachof one or more nerve pathways at a repetition rate or time sequencechosen or calculated to generate a given sensation for the patient). Insome embodiments, an external sensor is used to gather information aboutthe environment (e.g., a pressure sensor, an audio sensor, a videoimages sensor, or information from a gyroscope sensor, tilt sensor,temperature sensor, chemical or odor sensors or the like), whichinformation is optionally processed external to the patient, and theresulting data is wirelessly transmitted (e.g., using radio waves) to animplanted device 203 internal to the patient. Thus, in some embodiments,a sensation of touch or feeling is obtained using device 203. In otherembodiments, other sensations such as balance, vertigo or the avoidanceof vertigo, tilt, vision, touch, smell, or other sensation is obtainedusing device 203, wherein the given sensor(s) are collecting sensorydata and device 203 is generating the corresponding sensation, dependingon the location where the ends of the optical fibers (or bundle ofoptical fibers) and optionally electrical conductors are delivering theoptical signals and optionally the electrical signal(s) orpre-conditioning stimulus. In other embodiments, a motor response(rather than a sensation) of the patient is obtained, such as a limb,hand, eye, or tongue movement and/or the like. By implanting thelight-emitting end of the optic-fiber bundle of device 203 in or alongmotor nerves of the spinal cord or peripheral nerve system, other motorresponses (muscle contractions) may be obtained.

In some embodiments, the optical-fiber bundle end of device 203 issituated in or along a spinal nerve and or multiple spinal nerves of theperipheral nervous system (PNS), or in or along a nerve or nerve bundleof the spinal cord of the central nervous system (CNS), or even in oralong the brainstem or the side of the higher brain centers such as thecerebral cortex. In some embodiments, the optical-fiber bundle end ofdevice 203 is situated in or along the limbic system (e.g., thalamus,hypothalamus, amygdala, and/or hippocampus), or the pituitary gland,cerebellum, or corpus callosum.

Spinal nerves in the human body are formed from nerve fibers from boththe dorsal and ventral roots of the spinal cord, with the dorsal rootscarrying sensory information from the distal end of the PNS to thespinal cord and brain of the CNS and the ventral roots carrying motorfunction information from the brain and spinal cord to the distal endsof the PNS. The spinal nerves split off from the spinal cord and exitfrom the spinal column through the intervertebral foramen openingbetween adjacent vertebrae. After leaving the spinal column andsplitting into the dorsal and ventral roots, the spinal nerves divideinto branches and extend to various locations and in the body to detectand communicate sensory and motor information between the PNS and theCNS.

The human brain has twelve pairs of special nerves called the cranialnerves. These are specific bundles of neurons and axons which transmitspecial information to and from the brain, without going through thespinal cord. The cranial nerves each provide highly specific functions(sensory or motor). The cranial nerves all exit from the bottom of thebrain and brainstem and exit the skull through various foramina to reachtheir sources or targets. In some embodiments, the optical-fiber-bundlelight-delivery (and optionally electrical-stimulation) end of device 203is situated in or along one or more of the cranial nerves to obtain oneor more of the following responses of Table 1:

TABLE 1 CRANIAL NERVE NAME MAIN FUNCTION Cranial Nerve I Olfactory NerveSmell Cranial Nerve II Optic Nerve Vision Cranial Nerve III OculomotorNerve Eye movement Cranial Nerve IV Trochlear Nerve Eye movement CranialNerve V Trigeminal Nerve Facial sensation Cranial Nerve VI AbducensNerve Eye movement Cranial Nerve VII Facial Nerve Facial movementCranial Nerve VIII Auditory Nerve Hearing and balance Cranial Nerve IXGlossopharyngeal Nerve Organs and Taste Cranial Nerve X Vagus NerveOrgans and Taste Cranial Nerve XI Accessory Nerve Shoulder shrug & headturn Cranial Nerve XII Hypoglossal Nerve Tongue movement

In some such embodiments, wherein the optical-fiber bundle end of device203 is situated in or along the brainstem (the medulla, pons and/ormidbrain), or along the cranial nerves, or even in or along side of thehigher brain centers such as the cerebral cortex or wherein theoptical-fiber bundle end of device 203 is situated in or along thelimbic system (e.g., thalamus, hypothalamus, amygdala, and/orhippocampus), or the pituitary gland, cerebellum, or corpus callosum,optical pulses and/or a combination of electrical pulses and opticalpulses are used to generate a desired response in a particular nerve ornerves to sense an external stimuli (e.g., a smell, a visual stimuli, ora taste, and/or the like) or to provide a motor control signal to aportion of the body (e.g., to move the tongue or eyes, to turn the head,or to smile, and/or the like). In some embodiments, the nerve that isbeing stimulated or activated has been damaged or severed in a locationthat is between the distal end of the nerve and the brainstem, cranialnerves, or higher brain centers and therefore sensory signals comingfrom the distal end of the nerve are not able to reach the CNS forprocessing and motor signals coming from the CNS are not able to reachthe distal end of the nerve to provide the desired motor movement.

FIG. 3 is a schematic block diagram of nerve stimulator 301, accordingto some embodiments of the present invention. In some embodiments, nervestimulator 301 is completely implanted into a patient (e.g., a humananimal or a non-human animal) and is completely contained within thepatient with no ports or connections extending from internal to thepatient across the patient body boundary 98 and then external to thepatient. In some such embodiments, nerve stimulator 301 includesrechargeable batteries to provide power to the stimulator and power isprovided to the implanted nerve stimulator 301 from outside of the bodyusing wireless charging 341 (e.g., in some embodiments, inductivebattery charging) such that the batteries can be recharged without theneed to perform surgery to gain access to the stimulator. Also, in somesuch embodiments, nerve stimulator 301 includes a wirelesscommunications transmitter/receiver to receive information from outsidethe body (e.g., in some embodiments information received by stimulator301 from outside the body includes environmental data, sensory data,and/or stimulator operational instructions and programming, and/or thelike) and to transmit information from stimulator 301 to outside thebody (in some embodiments, information sent by stimulator 301 to outsidethe body includes stimulator error codes, stimulator diagnostics, and/orstimulator operational condition information, and/or the like). In otherembodiments, nerve stimulator 301 is partially implanted into thepatient such that the nerve stimulator 301 is not completely containedwithin the patient's body (i.e., at least a portion of the nervestimulator 301, including, but not limited to, a port or a connection)crosses the patient body boundary 98 and resides external to thepatient. In some such embodiments, power and data communications betweennerve stimulator 301 and power and/or devices is provided via electricalcables and connectors. Some embodiments include an external-to-the-bodyportion that includes sensors (e.g., microphones, accelerometers,gyroscopes, magnetometers, pressure sensors, moisture sensors, lightsensors (for one or more ultraviolet, visible, and/or infraredwavelengths), chemical sensors, imaging devices, radio-wave antennae,temperature sensors, and the like), electrical power, programming,input/output signals, transmitter/receiver and/or other devices.

In some embodiments, nerve stimulator 301 includes implant housing 342configured to contain the electrical and optical components of nervestimulator 301 and formed from a bio-compatible material, a battery pack349 configured to be rechargeable and to receive the recharge viainductive charging while the stimulator 301 is implanted in the patientand further configured to provide power to control unit 343. In someembodiments, control unit 343 is configured to contain electrical andoptical components including the communication electronics configured toreceive and transmit information from and to the outside of thepatient's body and laser-diode driver(s) configured to drive laserdiode(s) 344. Laser diode(s) 344 include one or more semiconductor laserdiodes (e.g., vertical-cavity surface-emitting lasers (VCSELs) oredge-emitting diode lasers) that are driven by the laser-diode driver(s)and configured to output laser light pulses 309 in the visible and/orinfrared wavelength radiation. In some embodiments, laser light pulses309 enter a light-shaping element 345 that is configured to shape thelight pulse and then output the shaped light pulse to waveguide 346. Insome embodiments, waveguide 346 is configured to direct the light pulseto a specific location where the light pulse is controlled bylight-delivery control 347 to illuminate a specific location on nervetissue 99 in order to activate a nerve action potential (NAP) in nerve99. In some embodiments, the heat 308 generated by the controlelectronics, laser diode drivers, and the communication electronicscontained in control unit 343, and by laser diode(s) 344 is removed fromnerve stimulator 301 via a heat sink 348 that is thermal-conductivelyconnected to control unit 343 and/or laser diode(s) 344 to transfer theheat 308 from control unit 343 and/or laser diode(s) 344 to heat sink348. In some embodiments, at least a portion of heat sink 348 extendsbeyond the outside boundary of nerve stimulator 301 in order fortransferred heat 308 to be removed from the heat sink 348 by allowingthe heat 308 to transfer and spread away from nerve stimulator 301 anddissipate inside the patient's body. In some other embodiments, heatsink 348 is completely contained within nerve stimulator 301 and makes athermally conductive contact with the inside surface of nerve stimulator301 such that the entire container acts as a heat transfer surface todissipate the heat 308 into the patient's body. In some embodiments, theimplant housing 342 is made of a heat-conducting bio-compatible materialthat has a relatively large thermal mass that readily absorbs short heatspikes from the laser-diode drivers 343 and the laser diodes 344 andthen dissipates the heat over a longer period of time to the body ofpatient 98. In some embodiments, the inner surface of implant housing342 includes an inside layer (e.g., in some embodiments, 0.5 mm to 3 mmthick) of very-high thermal-conductivity material (e.g., in someembodiments, a layer of materials having sufficient thermal conductivitysuch as copper, silver, diamond, graphite, graphite fibers, diamond-likecarbon (DLC), carbon nanotubes (CNT), silicon carbide, aluminum nitride,and the like, or a hybrid combination of one or more the above-listedmaterials filled or coated with a high-heat-capacity material such asparaffin wax, polyimide, and the like) that readily absorbs short heatspikes from the pulsed signals (which can be 1 microsecond to 0.01seconds or somewhat longer in duration), wherein the inner portion isencapsulated by an outer layer of (e.g., in some embodiments, thinner)biocompatible material such as titanium, polyimide-coated CNTs orgraphite fibers, or a polymer, which has a lower (but not too low)thermal conductivity to dissipate the heat over a longer period of time(e.g., 10 to 100 seconds) in order to prevent thermal damage to thetissue surrounding implant housing 342.

FIG. 4 is a schematic drawing of a plurality of light-delivery options401 from fiber optics/waveguides. In some embodiments, the shape of thelaser beam delivered by the fiber is accomplished with a lens, polishedtip (facetted or shaped), grating, mirror or reflective coating, or somecombination of the above. Waveguide 411 ends in an angled facet and/orfiber-Bragg grating that reflects or diffracts the light out in a radialor side (“side firing”) direction of the waveguide as laser beam 81.Waveguide 412 ends in an end facet that transmits the light out in anaxial direction of the waveguide as laser beam 82. Waveguide 413 ends ina conical (as shown), rough or ground “frosted” end that diffuses thelight out in a generally axial direction of the waveguide as laser beam83. Waveguide 414 ends in a lens-type end facet that transmits anddiverges the light out in an axial direction of the waveguide as laserbeam 84. Waveguide 415 ends in a lens-type end facet that transmits andfocuses the light out in an axial direction of the waveguide as laserbeam 85. Waveguide 416 ends in a lens-type end facet that transmits andcollimates the light out in a parallel beam in an axial direction of thewaveguide as laser beam 86. Waveguide 417 ends in an annular lens-typeend facet that transmits and focuses the light out in a conical ringcentered about an axial direction of the waveguide as laser beam 87. Insome such embodiments, the very end facet is polished and coated with ametallic or dielectric-layered reflective structure to better facilitatethe ring-shaped output beam 87. Waveguide 418 has a mid-fiber orend-fiber grating that disperses light of a selected wavelength in aradial direction from the side of the fiber of the waveguide as laserbeam 88. In some embodiments, a combination of two or more of suchfeatures as shown in fiber ends 411, 412, 413, 414, 415, 416, 417 and/or418 are applied to a single fiber tip to provide a hybrid beam shapecombining some aspects of beams 81, 82, 83, 84, 85, 86, 87 and/or 88,respectively. In some embodiments, a bundle having a plurality of suchfibers and ends are used in combination to get a plurality of beamsand/or a plurality of beam shapes in a small area. In some embodiments,the ends of the plurality of fibers terminate at a plurality ofdifferent axial lengths to provide output beams that leave the bundle atdifferent points along the length of the fiber bindle.

FIG. 5 is a schematic representation of a plurality of nerve stimulatorlight delivery options 501, according to some embodiments of the presentinvention. In some embodiments, the present invention provides aplurality of light-delivery techniques for stimulating nerve 11,specific fascicle 12 (i.e., a specific bundle of nerve fibers 12) withinthe nerve 11, or even a specific individual nerve fiber 13 within thefascicle 12 in the peripheral nervous system (PNS) and/or the centralnervous system (CNS), including cranial nerves, of an animal. In someembodiments, the light-delivery technique is non-invasive to the nerve11, fascicle 12, and/or nerve fiber 13 because the light-deliverytechnique does not penetrate the surface of the nerve 11. In some otherembodiments, the light-delivery technique is considered invasive to thenerve 11 because waveguides, optical-electrodes, and/or the likepenetrate the outer surface of the nerve 11 in order to providestimulation of fascicles 12 or nerve fibers 13 that are located on theinterior of the nerve 11. In some embodiments, a non-invasivedirect-light technique is used to stimulate a nerve 11, fascicle 12,and/or nerve fiber 13, or a combination of a nerve 11, fascicle 12,and/or nerve fiber 13 using laser-light beam 552. In some embodiments,non-invasive direct-light technique provides a laser-light beam 552 froma laser-source module (LSM) and/or light-shaping element (LSE), asdescribed above for FIG. 4, to stimulator the nerve 11, fascicle 12,and/or nerve fiber 13. In some embodiments, remote LSM and/or LSE isused to stimulate one or more areas of nerve 11, fascicle 12, and/ornerve fiber 13, wherein light is transmitted via a fiber bundle 551 atthe fiber 551/nerve 11 interface, wherein, in some embodiments, thelight is emitted from the end of fiber bundle 551 and/or light isemitted from multiple locations along the fiber bundle 551 using inlinefiber gratings. In some embodiments, an invasive method is used tostimulate the nerve 11 using a light-transmitting waveguide array 553implanted into nerve 11, fascicle 12, and/or nerve fiber 13 (attached toLSM or LSE) and formed from transmissive material made by micro-molding,micro-machining, and/or photolithography. In some other embodiments, anadditional invasive method is used to stimulate the nerve 11 byimplanting a power distribution strip 554 that includes a plurality oflight emitting devices that are each capable of stimulating nerve 11,fascicle 12 and/or individual nerve fiber 13. In some embodiments, acombination of light delivery options are used to stimulate nerve 11,fascicle 12, and/or nerve fiber 13 (i.e., in some embodiments, acombination of one or more of the described techniques, including,laser-light beam 552, fiber bundle 551, waveguide array 553, and/orpower-distribution strip 554 are used for stimulating nerve 11, fascicle12, and/or nerve fiber 13).

FIG. 6A is a cross-section end-view schematic representation of acircular-cuff nerve stimulator 601, according to some embodiments of thepresent invention. In some embodiments, circular-cuff nerve stimulator601 includes one or more vertical cavity surface emitting lasers(VCSELs) 644 configured to emit light at a wavelength used to stimulatea nerve 11, fascicle 12, or individual nerve fiber 13, one or moredriver integrated circuits 643 that are configured to provide thedriving power required to operate the VCSELs 644, power-and-controlelectronics 663 configured to provide power to the driver ICs andcontrol which VCSELs 644 are emitting optical radiation and thereforeproviding stimulation to the nerve 11, fascicle 12, or individual nervefiber 13. In some embodiments, circular-cuff nerve stimulator 601 iswrapped around or surrounds one or more nerves 11 and the VCSELs areused to stimulate specific areas in nerve 11, specific fascicles 12,and/or even specific individual nerve fibers 13, or a combination of thethree. In some embodiments, the control electronics that control thestimulation signals are mounted with or integrated with the VCSELdrivers 643.

In some such embodiments, each VCSEL emits a somewhat narrow cone-shapedor substantially collimated beam that stimulates only a relatively smallamount of tissue or number of nerve fibers. In some embodiments, thenarrow beam illuminates a plurality of nerves along its axial length,but wherein pulses from a single such narrow beam are insufficient totrigger a NAP in any one of these plurality of illuminated nerve fibers.Only when a plurality of such narrow beams intersect at one or morenerve fibers, such that optical pulses from the plurality of beams aredelivered within a sufficiently short amount of time to the intersectionpoint or volume of tissue and thus the combination of intersectingpulses (close enough in space and in time) are sufficient to trigger aNAP.

FIG. 6B is a side-view schematic representation of an encircling-cuffnerve stimulator 602, including control electronics 663, according tosome embodiments of the present invention. In some embodiments,encircling-cuff nerve stimulator 602 is substantially similar tocircular-cuff nerve stimulator 601, except that the control electronics663 of encircling-cuff nerve stimulator 602 are not integrated with theVCSEL drivers as shown in FIG. 6A for circular-cuff nerve stimulator601, but rather are located at a distal end of electrical cable 662(which allows the heat from the electronics drivers to be dissipatedover a larger area, thus reducing patient discomfort and the chance forinjury). In some embodiments, the VCSEL drivers 643 are also locateddistal to the nerve being stimulated (e.g., in some embodiments, thesedrivers are located with or integrated with the control electronics664). Electrical signals in cable 662 connect control electronics 663 todriver integrated circuits 643. In some embodiments, control electronics663 are in a biocompatible housing implanted into the patient. In otherembodiments, control electronics 663 are partially implanted into thepatient such that the control electronics 663 is not completelycontained within the patient's body and at least part of controlelectronics 663 control signals and/or power crosses the patient bodyboundary (e.g., by wireless signal and power transmission), and at leastpart of control electronics 663 resides external to the patient.

In some embodiments, the electrical signals in cable 662 are multiplexedto reduce the number of wires and/or size of the cable connecting thecontrol electronics to the VCSEL drivers 643. In some embodiments, theelectrical signals in cable 662 are time-division multiplexed orserially multiplexed. In some embodiments, the electrical signals incable 662 are multiplexed by being encoded, such as row-columnmultiplexed (e.g., where the cathodes of the VCSELs are connected in aplurality of columns and the anodes are connected in a plurality ofrows). In some other embodiments, other commonly known methods ofmultiplexing are use to reduce the number of wires and/or size of thecable connecting the control electronics to the VCSEL drivers 643. Insome such embodiments, VCSEL-driver circuit 643 includes a demultiplexorand/or decoder that uses the information in signals from cable 662 toactivate selected ones of the VCSELs at the appropriate times to triggerthe desired response.

In some embodiments, the number of individually-controllable VCSELsselectively emitting optical radiation is greater or much greater thanthe number that will be end up being used in normal operation. With alarge number of VCSEL elements, empirical testing can be used, in someembodiments, to determine which individual VCSEL elements orcombinations of VCSEL elements stimulate the desired response from afascicle or nerve fiber. With such empirical testing, it is notnecessary to precisely locate unit 602 relative to any one or morenerves in a tissue nor is it required to detect a NAP in a particularnerve near the stimulation; rather, the device is implemented with manymore VCSEL elements than the number of nerves to be stimulated, it isimplanted or placed in an approximate position, and then tested toobtain stored mapping information (e.g., by emitting a light pulse fromone or more light emitters, and determining which, if any, response wastriggered (e.g., by observing muscle movement or inquiring of thepatient what if any sensation was felt), and storing into a computermemory which response(s) was generated by light and/or electricalsignals from which emitters and/or electrodes), then using that storedinformation as a map (between later-detected conditions for whichresponses are to be triggered, and which emitters and/or electrodes areto be activated to evoke the respective response for the detectedcondition).

In some embodiments, a plurality of circular-cuff nerve stimulators 602are used and connected by electrical signals 662 to one or more sets ofcontrol electronics 663. In some embodiments, a plurality ofcircular-cuff nerve stimulators 602 are placed along one or more nerves11.

In some embodiments, encircling-cuff nerve stimulator unit 602 isflexible and spiral shaped to allow the encircling-cuff to be insertedaround the nerve 11 by twisting the spiral-shaped nerve stimulators 602around the nerve. In some embodiments, flexible spiral-shaped nervestimulators provide a close fit over a wide variety of nerve geometrieswithout pinching the nerve and this close fit also provides for a morestable (e.g., less chance of movement) arrangement between the nervestimulator device and the nerve. In some embodiments, the spiral-shapednerve stimulators provide for several loops around the nerve in ahelical arrangement providing additional VCSELs 644 to optionally orselectively stimulate a plurality of nerve(s) 11, fascicles 12, and/ornerve fibers 13.

In some embodiments, power levels for a single VCSEL are low enough notto stimulate a NAP, while the power level resulting from substantiallysimultaneous light pulses from a plurality of VCSELs is used tostimulate a NAP. To stimulate fascicles, and/or nerve fibers that happento be located deeper within a nerve tissue, in some embodiments it isdesirable to limit the output power level of a single VCSEL to a valuethat is below the level that would stimulate a NAP.

In some embodiments, a plurality of VCSELs ‘dynamic focussing’ laserenergy deeper into the nerve tissue, i.e., ‘dynamic focussing’ laserenergy is the intersection of the simultaneously delivered pulses oflight from a plurality of VCSELs on a fascicle or nerve fiber. In someembodiments, a plurality of VCSELs each have differently-focused tips oroutput optics (e.g., waveguide 415 described above in FIG. 4) such thata plurality of VCSELs, each focused at one of a variety of focal lengthscan be separately activated to achieve different depths at which thelight simulation becomes focussed enough to trigger a NAP. With a numberof VCSELs each focused at a variety of focal lengths, empirical testingcan be used, in some embodiments, to determine which individual VCSELstimulates the desired response from a fascicle or nerve fiber. (Notethat with such empirical testing, it is not necessary to preciselylocate unit 602 relative to any one or more nerves in a tissue; rather,the device is implemented with many more VCSEL elements than the numberof nerves to be stimulated, and testing (e.g., emitting a light pulsefrom one or more light emitters, and determining which, if any responsewas triggered, and storing into a computer memory which response(s) wasgenerated by which emitters, then using that stored information as a mapas to which emitters to activate to evoke which response) is used todetermine the VCSEL element to use to stimulate a desired response.) Insome embodiments, a combination of ‘dynamic focussing’ a plurality ofVCSELs and lens focusing at a variety of focal lengths are used toselectively stimulate fascicles and/or nerve fibers deep within a nerve11 without stimulating non-selected fascicles or nerve fibers closer tothe epineurium of the nerve.

FIG. 7A is a cross-section end-view schematic representation of amultiple-wavelength nerve stimulator 701, according to some embodimentsof the present invention. In some embodiments, multiple-wavelength nervestimulator 701 includes one or more optical fibers (761, 762, 763) eachconfigured to transmit a different wavelength of laser light (λ₁, λ₂,λ₃, respectively) to stimulate nerve 11 and each optical fiber (761,762, 763) includes an output feature (such as a fiber grating as shownschematically in fiber 418), each configured or tuned to output, at eachfiber's grating, termination or window (e.g., such as shown in FIG. 4),one of the specific laser-light wavelengths (λ₁, λ₂, λ₃, respectively)traveling through the optical fiber (761, 762, 763). In someembodiments, different wavelengths of laser-light are used to penetrateto different depths with the nerve 11. In some embodiments, an outputlens on each fiber having one of a plurality of focal lengths is used toobtain one of a plurality of tissue-penetration depths (in that onlywhen the light is at the focal point will the light have sufficientpower-per-area to trigger a NAP), in order that beams emitted from eachof a plurality of fibers trigger NAPs in different nerves. In someembodiments, a testing algorithm is used to determine which response istriggered by each of a plurality of fibers and a mapping of which fibertriggers which response is programmed or stored into the controllerelectronics in order to properly stimulate one of a plurality ofresponses when desired. In some embodiments, the fiber grating inoptical fiber 761 is tuned to laser-light wavelength λ₁ and the gratingreflects the laser-light traveling in optical fiber 761 causing thelaser light to exit the fiber such that the emitted laser lightstimulates a portion of nerve 11 (e.g., one or more fascicles 12 and/orone or more axons 13). In some embodiments, the fiber grating in opticalfiber 762 is tuned to laser-light wavelength λ₂ and the grating reflectsthe laser-light traveling in optical fiber 762 causing the laser-lightto exit the fiber such that the emitted laser light stimulates a portionof nerve 11 (e.g., one or more fascicles 12 and/or one or more axons13). In some embodiments, the fiber grating in optical fiber 763 istuned to laser-light wavelength λ₃ and the grating reflects the laserlight traveling in optical fiber 763 causing the laser light to exit thefiber such that the emitted laser light stimulates a portion of nerve 11(e.g., one or more fascicles 12 and/or one or more axons 13). In someembodiments, the each optical fiber includes a single fiber grating toreflect the laser light onto the nerve and in other embodiments eachoptical fiber includes a plurality of fiber gratings to such that eachoptical fiber can stimulate the nerve in multiple positions along theoptical fiber. In some embodiments, the optical fibers are spirallywound along the length of the nerve or are wound in a circular manneraround the nerve.

In some embodiments, the one or more optical fibers (761, 762, 763)include faceted ends (e.g., cleaved, lensed or polished ends), whereinthe face or facet of each faceted end of the one or more optical fibers(761, 762, 763) reflects and/or focusses the laser-light that wastraveling in an axial direction in the one or more optical fibers (761,762, 763) causing the laser light to exit the fiber in a radial orangled direction such that the emitted laser light stimulates a portionof nerve 11 (e.g., one or more fascicles 12 and/or one or more axons 13)

FIG. 7B is a side-view schematic representation of a multiple-wavelengthnerve stimulator 702, according to some embodiments of the presentinvention. In some embodiments, multiple-wavelength nerve stimulator 702includes one or more laser-beam sources (771, 772, 773) each having adifferent wavelength (λ₁, λ₂, λ₃, respectively) and each being opticallyconnected by a waveguide 764 to a beam combiner 765 where the laserlight of each laser source (771, 772, 773) is combined and transmittedto optical waveguide 767. In some embodiments, different wavelengths oflaser-light are used to stimulate different portions of nerve 11 whilesharing a common optical waveguide (e.g., if different wavelengths havedifferent penetration depths in a given tissue, in some embodiments,those wavelengths with short penetration depth stimulate tissue nearerthe surface and those wavelengths with longer penetration depthstimulate tissue further from the surface). In some embodiments, opticalwaveguide 767 is configured to receive the laser light having multiplewavelengths (λ₁, λ₂, λ₃, respectively) and fiber gratings (grating 781,grating 782, and grating 783, respectively) are placed, as shown in FIG.7B, such that different wavelengths of light are emitted from thewaveguide through optical windows 766 generating optical beams 791, 792,and 793, respectively, located at different axial locations along anerve 11. The fiber gratings and optical windows are placed, e.g., asshown in FIG. 7B, such that different wavelengths emitted from thewaveguide are located at different transverse locations along the lengthof the nerve, and in some other embodiments, a combination of multiplewavelengths are emitted both axially and transversely locations areprovided as a function of the wavelength. In some embodiments, theoptical waveguide 767 is spirally wound along a length of the nerve oris wound in a circular manner around the nerve and the optical gratingsare distributed in a circular or helical/spiral cuff configurationaround the nerve.

FIG. 7C is a cross-section end-view schematic representation of amultiple-focal-length nerve stimulator 703, according to someembodiments of the present invention. In some embodiments, a pluralityof VCSELs each have differently-focused tips or output optics (e.g.,waveguide 415 described above in FIG. 4) such that a plurality of VCSELs(e.g., 751, 752, 753, 754, 755, 756 and 757), each focused at one of avariety of focal lengths can be separately activated to achievedifferent depths at which the light simulation becomes focussed enoughto trigger a NAP. In some embodiments, the emitters of the plurality ofVCSELs are located around and in close proximity with the nerve 11(e.g., arranged around nerve 11 as described above in FIGS. 6A and 6B).In some embodiments, many more VCSELs/lenses are used than demonstratedin FIG. 7C. With a number of VCSELs each focused at a variety of focallengths, empirical testing can be used, in some embodiments, todetermine which individual VCSEL stimulates the desired response from afascicle or nerve fiber. Note that with such empirical testing, it isnot necessary to precisely locate unit 703 relative to any one or morenerves in a tissue; rather, the device is implemented with many moreVCSEL elements than the number of nerves to be stimulated, and testingis used to determine the VCSEL element to use to stimulate a desiredresponse.

Thus, in some embodiments, the present invention provides a method thatincludes selectively controlling light signals having a wavelength andhaving a pulse duration from each of a plurality of vertical cavitysurface-emitting lasers (VCSELs) including a first VCSEL 751 and asecond VCSEL 752; focussing the light from the first VCSEL 751relatively more deeply into first tissue 11 of the patient (e.g., 98 ofFIG. 3), in order to stimulate the NAP in a first nerve fiber 711 thatis deeper in the first tissue 11 than a second nerve fiber 712 that isat or nearer to a surface-layer depth in the first tissue 11 adjacentthe first VCSEL 751 and second VCSEL 752 without stimulating a NAP inthe second nerve fiber 712 due to the light from the first VCSEL 751;and focussing the light from the second VCSEL 752 to focus less deeplyinto the first tissue 11 of the patient, in order to stimulate the NAPin the second nerve 712 (which is at a shallower depth in the firsttissue) adjacent the first VCSEL 751 and second VCSEL 752 withoutstimulating a NAP in the deeper first nerve 711 due to the light fromthe second VCSEL 752.

In other embodiments, the focussed light from each VCSEL 751, 752, 753is insufficient alone to trigger a NAP in nerves 711, 712, or 713, butwhen a pulse is emitted from VCSEL 751 substantially simultaneously witha pulse emitted from VCSEL 752, the light from VCSEL 751 focussed onnerve fiber 711 and the extra light from VCSEL 752 (perhaps not focussedon nerve fiber 711) are sufficient to trigger a NAP in nerve fiber 711but, due to their various directions and focal-point distances andlocations would perhaps not trigger a NAP in nerve fiber 712.

In still other embodiments, the focussed light from each VCSEL 754, 755,756, 757 are each insufficient alone to trigger a NAP in nerve fibers714 and 715, but a plurality of VCSELs (e.g., the pair 754 and 755 eachfocussed and pointed to converge into a single nerve fiber 714, or thepair 756 and 757 each focussed and pointed to converge into anothersingle nerve fiber 715. When stimulation light is emitted and focussedby both VCSELs 754 and 755, that combined light will trigger a NAP innerve fiber 714, and similarly when stimulation light is emitted andfocussed by both VCSELs 756 and 757, that combined light will trigger aNAP in nerve fiber 715.

In some embodiments, an electrical-signal controller (such as shown inFIGS. 2A, 2B, 2C and 2D) is added to the embodiments of any of the otherFigures herein, such that a combination of electrical stimulation andoptical stimulation (wherein either alone is insufficient to trigger aNAP) is used wherein when applied in combination the combination ofelectrical stimulation and optical stimulation is sufficient to triggera NAP. In some such embodiments, the optical stimulation includesstimulation light from a plurality of VCSELs that is emittedsimultaneously or non-simultaneously but close enough in time so as tosynergistically combine with each other and with the electricalstimulation to reliably trigger a NAP.

FIGS. 7D1, 7D2, and 7D3 are cross-section end-view schematicrepresentations of a multiple-intersection nerve stimulator 704,according to some embodiments of the present invention. In someembodiments, power levels for a single VCSEL are low enough not tostimulate a NAP, while the power level resulting from substantiallysimultaneous collimated light pulses from a plurality of VCSELs is usedto stimulate a NAP. To stimulate fascicles, and/or nerve fibers thathappen to be located deeper within a nerve tissue, in some embodimentsit is desirable to limit the output power level of a single VCSEL to avalue that is below the level that would stimulate a NAP. In a firstexample, FIG. 7D1 is a schematic representation where the combination ofindividual VCSELs 741, individual VCSELs 742, and individual VCSEL 743,simultaneously deliver sufficient collimated pulse light power tofascicles and/or nerve fibers 714 to stimulate and NAP. Pulse lightpower from each individual VCSEL 741, 742, and 743 is insufficient tostimulate a NAP, thus not stimulating other fascicles and/or nervefibers with the nerve 11.

In a second example, FIG. 7D2 is a schematic representation where thecombination of individual VCSELs 741, individual VCSELs 742, individualVCSELs 743, and individual VCSEL 744, simultaneously deliver sufficientcollimated pulse light power to fascicles and/or nerve fibers 714 tostimulate and NAP. Pulse light power from each individual VCSEL 741,742, 743, and 744 is insufficient to stimulate a NAP, thus notstimulating other fascicles and/or nerve fibers with the nerve tissue11.

In a third example, FIG. 7D3 is a schematic representation where thecombination of individual VCSELs 741, individual VCSELs 742, individualVCSELs 743, and individual VCSEL 744, simultaneously deliver sufficientcollimated pulse light power to fascicles and/or nerve fibers 715 tostimulate and NAP. Pulse light power from each individual VCSEL 741,742, 743, and 744 is insufficient to stimulate a NAP, thus notstimulating other fascicles and/or nerve fibers with the nerve tissue11. In some embodiments, the number of VCSELs used is much greater thanshown in these examples, but it demonstrated by these examples howindividual fascicles and/or nerve fibers can be stimulated using aplurality of VCSELs located around and in close proximity with the nerve11 (e.g., arranged around nerve 11 as described above in FIGS. 6A and6B). With a combination of VCSELs intersecting at a variety of pointswithin a nerve 11, empirical testing can be used, in some embodiments,to determine which combination of VCSELs stimulate the desired responsefrom a fascicle or nerve fiber. Note that with such empirical testing,it is not necessary to precisely locate unit 704 relative to any one ormore nerves in a bundle; rather, the device is implemented with manymore VCSEL elements than the number of nerves to be stimulated, andtesting is used to determine the VCSEL element to use to stimulate adesired response.

FIG. 8 is a cross-section end-view schematic representation of atransversely-implanted nerve stimulator 801, according to someembodiments of the present invention. In some embodiments, aone-dimensional (1D—e.g., a single needle-like projection) array or atwo-dimensional (“2D”—e.g., a row of parallel needle-like projections asshown in FIG. 8) array of mechanical supports 861 are used to support aplurality of VCSELs 844, wherein each support locates each of itsemitters at a different one of a plurality of depths within the group ofnerves within nerve tissue 11 such that the light from each VCSEL 844 isemitted at a different nerve within the group. In some embodiments, the1D or 2D array of supports is gently “teased” through the nerve bundleso as to not damage the nerves during the insertion. In someembodiments, some of the supports 861 may be different lengths than theothers and/or penetrate group of nerves in the nerve tissue to varyingdepths. In some embodiments, single or multiple VCSELs 844 are packagedon each support. In some embodiments, VCSELs on given support deliverlight in a single radial direction (e.g., VCSELs in a line along oneside of the support emitting substantially parallel beams in a singleradial direction) or in multiple directions (e.g., VCSELs located onmultiple sides of the support emitting non-parallel beams in a pluralityof radial directions). In some embodiments, VCSELs may be placed atfixed depths along supports and the supports are inserted to differentdepths (like changing the lengths of the support extending from theVCSEL-driver integrated circuit (IC) 843). In some embodiments, othersupport-tip geometries capable of penetrating nerve are used. In otherembodiments, the VCSELs are located distal from the supports 861, andoptical fibers or other light-guiding structures carry the light fromthe VCSELs to the emitters on the needle-like supports 861, which areinserted within the group of nerves in nerve tissue 11. In someembodiments, electrical signals in cable 862 connect control electronics863 to driver integrated circuit(s) 843. In some embodiments, controlelectronics 863 are in a biocompatible housing implanted into thepatient. In other embodiments, control electronics 863 are partiallyimplanted into the patient such that the control electronics 863 is notcompletely contained within the patient's body and at least part ofcontrol electronics 863 control signals and/or power crosses the patientbody boundary (e.g., by wireless signal and power transmission), and atleast part of control electronics 863 resides external to the patient.

In some embodiments, the electrical signals in cable 862 are multiplexedto reduce the number of wires and/or size of the cable connecting thecontrol electronics 863 to the VCSEL-driver circuit(s) 843. In someembodiments, the electrical signals in cable 862 are time-divisionmultiplexed or serially multiplexed. In some embodiments, the electricalsignals in cable 862 are multiplexed by being encoded, such asrow-column multiplexed (e.g., where the cathodes of the VCSELs areconnected in a plurality of columns and the anodes are connected in aplurality of rows). In some other embodiments, other commonly knownmethods of multiplexing are use to reduce the number of wires and/orsize of the cable connecting the control electronics to the VCSELdrivers 843. In some such embodiments, VCSEL-driver circuit 843 includesa demultiplexor and/or decoder that uses the information in signals fromcable 862 to activate selected ones of the VCSELs at the appropriatetimes to trigger the desired response.

In some embodiments, the number of individually-controllable VCSELsselectively emitting optical radiation is greater or much greater thanthe number of VCSELs that will be end up being used in normal operation.In some embodiments, the number of supports 861 is greater than thenumber that will be end up being used in normal operation. With a largenumber of VCSEL elements and/or supports 861, empirical testing can beused, in some embodiments, to determine which individual VCSEL elementsor combinations of VCSEL elements stimulate the desired response from afascicle or nerve fiber. With such empirical testing, it is notnecessary to precisely locate unit 801 relative to any one or morenerves in a tissue; rather, the device is implemented with more or manymore VCSEL elements and supports 861 than the number of nerves to bestimulated, and testing (e.g., emitting a light pulse from one or morelight emitters, and determining which, if any response was triggered(e.g., by observing muscle movement or inquiring of the patient what ifany sensation was felt), and storing into a computer memory whichresponse(s) was generated by which emitters and/or electrodes), thenusing that stored information as a map (between later-detectedconditions for which responses are to be triggered, and which emittersand/or electrodes are to be activated to evoke the respective responsefor the detected condition).

FIG. 9A is a block diagram of a computerized system 901 for determininga reaction of the nerve tissue through empirical testing of thelight-emitting structure and power levels. In some embodiments, computersystem 904 is connected by a wired and/or wireless interface 920 to thecontrol electronics 863. In some embodiments, the present inventionprovides a method for a computerized method of determining whichcombinations of VCSELs, power levels, and wavelengths cause a reactionin the patient and storing that information for future reference andstimulation. This computerized method includes iteratively applying aplurality of different combinations of stimulation signals to thepatient and acquiring data as to one or more responses that were causedby each combination of stimulation signals, providing specifications ofa plurality of desired responses to each of a plurality of conditions,correlating and mapping the specifications of a plurality of desiredresponses with the data as to the responses that were caused by eachcombination of stimulation signals, and storing a resulting mapping in acomputer-readable memory, determining that one of the plurality ofconditions has occurred, and based on the stored mapping and thedetermination that one of the plurality of conditions has occurred,driving the corresponding combination of stimulations signals to evokethe desired response to the condition in the patient. In someembodiments, the method also provides input device(s) 905 connectedthrough an interface 906 as part of computer system 904 to provideexternal user or operator input as to the responses that were caused byeach combination of stimulation signals.

FIG. 9B is a block diagram of a computerized method 902 for determininga reaction of the nerve tissue through empirical testing of thelight-emitting structure, power levels and/or electricalpreconditioning, and then using the mapping obtained from the testing tocontrol a nerve stimulator. In some embodiments, method 902 includesstarting at block 921, then implanting or placing the nerve-stimulationdevice such that the optical- and/or electrical-signal deliver is at anefficacious location near or against the nerve tissue to be stimulated(e.g., as described above). At block 923, the method causes the deviceto deliver a combination of a plurality of optical signals within a timeperiod that is short enough that the combination will trigger a NAP. Theterm “a time period that is short enough” means that the optical signalsare either applied simultaneously, at least partially overlapped intime, or successively (but not simultaneously) but within a period oftime that is short enough that the pulses effect on tissue combinessufficiently to trigger a NAP. In some embodiments, either signal aloneis insufficient to trigger a NAP, while in other embodiments, one orboth signals may at least sometimes trigger a NAP. In some embodiments,in addition to the plurality of optical signals, anelectrical-sensitization signal must be applied before or during thetime period within which the combination of optical signals is applied.At block 924, the evoked NAP or other response is sensed to generate asense signal or sense data, which is then analyzed to determine whichphysiological response it was, and a mapping indication (of whichstimulation caused which response) is stored in a computer-accessiblememory or the equivalent. If a sufficient number and type of thepossible responses have been successfully evoked, the YES exit fromblock 925 is taken and the method continues at block 931, otherwise thecombination of specified outputs is changed and the method goes back toblock 923 and the method iterates until a sufficient set of responseshave been mapped. Of course, if all possible combinations of stimulationsignals have been tried, the method could go to block 931, or theimplantation could be repositioned by going to block 922.

At block 931, the method includes receiving one or more environmentaland/or patient-physiology signals or data (e.g., from an environmentalsensor, and/or from a patient-physiology sensor). At block 932, thesignals and/or data are analyzed to determine which response is desiredor needed, and at block 933, the method includes mapping the neededresponse indication to a set of stimulation-signal outputs that areneeded to evoke that response (e.g., the set of one or more NAPs thatshould be triggered). Typically the method then always goes back toblock 931 to wait for another sensed event, however, in someembodiments, the method determines that the required sensing andsimulations needed have been completed, and the method goes to the endblock 935.

In some embodiments (such as described in U.S. Pat. No. 7,736,382 issuedJun. 15, 2010, which is incorporated herein by reference), in thoseinstances where an array- or matrix-type configuration is used softwareis used to isolate an isomorphism between a particular light-emittingstructure and certain nerve tissues. Put another way, once a reaction ofa particular nerve tissue is determined, software can be used todetermine which light-emitting structure and power levels actuallycaused the reaction on the part of the nerve tissue. The algorithm todetermine which light-emitting structure and power levels caused areaction could be a simple sequential-search algorithm whereby eachlight-emitting structure individually emits light by itself at variouspower levels and a nerve-tissue reaction is determined to be present orabsent, or it could be a more sophisticated binary-search algorithmwhereby, for example, an array of light-emitting optical-fiberstructures is divided in half, each sub-array tested individually todetermine whether a nerve-tissue reaction is present or absent, and ifone sub-array is indeed associated with a nerve-tissue reaction thenthat sub-array is again divided in half and the process repeated. Someembodiments use algorithms to search array-like structures and matrices,such as are well known in the art. (See Algorithms in C++: Parts 1-43^(rd) Edition, by Robert Sedgewick, Addison Wesley 1998.) In someembodiments, stimulated nerve tissue reactions

In some embodiments, the present invention provides a method foractivating or stimulating neurons (peripheral or central projections) ofa nerve or nerve bundle of a patient to provide touch, feeling,temperature, pain, or motor sensations for the patient. In someembodiments, the method provides stimulation or inhibition of nervesignals for treatment of pain, obesity, epilepsy, depression, and thelike. In some embodiments, the method provides therapy that restoresmotor-nerve (muscle-control) signals from the brain towards muscles orprostheses (through NAP stimulation, inhibition, or both), for motorcontrol as well as treatment of incontinence, irregular heart rhythms,tremors or twitches, and the like. In some embodiments, the methodincludes delivering light signals, or both light and electrical signals,to a plurality of neurons of the nerves of the PNS and/or CNS of thepatient.

In some embodiments, the delivering of light signals includes deliveringthe light signals to peripheral projections of the neurons. In someembodiments, the delivering of light signals includes delivering thelight signals to central portions of the neurons.

In some embodiments, the delivering of light signals includes deliveringlight (having one or more ultraviolet, visible, and/or infraredwavelengths) from a laser or other light source. In some embodiments,the delivering of light signals includes delivering light from a VCSEL.In some embodiments, the delivering of light signals includes deliveringlight from a quantum-dot laser. In some embodiments, the delivering oflight signals includes delivering light from an edge-emitting laser. Insome embodiments, the delivering of light signals includes deliveringlight from a non-laser light-emitting device (LED). In some embodiments,the delivering of light signals includes delivering light from asuper-luminescent LED or other such light source.

Some embodiments further include delivering an electrical signal to aplurality of neurons of the nerves or nerve bundles of the PNS and CNS.

In some embodiments, the delivering of the light signals includesobtaining a plurality of light signals from one or more laser lightsources and delivering the obtained light signals to discrete portionsof excitable tissues, wherein the responses triggered by the lightsignals are interpretable by the patient's brain as sensory responses.

In some embodiments, the delivering of the light signals furtherincludes selectively controlling the light signals to opticallystimulate the neurons in order to control nerve action potentials (NAPs)produced by the one or more nerves. In some embodiments, the selectivelycontrolling the light signals includes controlling a pulse width of theplurality of light signals. In some embodiments, the selectivelycontrolling the light signals includes controlling a pulse repetitionrate of the plurality of light signals. In some embodiments, theselectively controlling the light signals includes controlling a pulseshape of the plurality of light signals. In some embodiments, theselectively controlling the light signals includes controlling a DCbackground amount of light intensity of the plurality of light signals.In some embodiments, the selectively controlling the light signalsincludes controlling a precharge amount of light intensity followed by atrigger amount of light intensity of the plurality of light signals. Insome embodiments, the selectively controlling the light signals includescontrolling the light signals to increase a frequency of the NAPsproduced by the one or more nerves that would otherwise occur withoutthe plurality of light signals.

In some embodiments, the method further includes applying a prechargecurrent of electrical energy that is followed by a trigger amount ofpulsed light intensity of the plurality of light signals.

In some embodiments, the obtaining the plurality of light signalsincludes implanting a self-contained battery-poweredlaser-light-generation device and obtaining the plurality of lightsignals from the battery-powered laser-light-generation device.

In some embodiments, the delivering the plurality of light signals tothe plurality of neurons of nerves of the PNS and/or CNS includespositioning a delivery end of one or more fibers against one or moreneurons of the PNS and/or CNS and using one or more optical fibers toguide the light signals from a laser source to the one or more neurons.

In some embodiments, the one or more laser light sources include a firstlight source and a second light source, wherein the selectivelycontrolling the plurality of light signals includes controlling thefirst light source to send a first series of pulses during a firstperiod of time and controlling the second light source to send a secondseries of pulses during the first period of time, and wherein the firstseries of pulses differs from the second series of pulses in repetitionrate.

In some embodiments, the present invention provides a method thatincludes obtaining a plurality of light signals from one or more laserlight sources; delivering the plurality of light signals to a pluralityof nerve pathways in the PNS and/or CNS of a living animal; andselectively controlling the plurality of light signals to opticallystimulate the plurality of nerve pathways in order to control nerveaction potentials (NAPs) produced by the plurality of nerve pathways. Insome embodiments, the plurality of nerve pathways in the PNS and/or CNSincludes spinal nerves pathways, cranial nerves pathways, brainstempathways, spinal cord pathways, and the like.

In some embodiments, the living animal is a human person. In someembodiments, the living animal is a large non-human animal, e.g., a racehorse, a Scottish Highland cow, a Black Guinea hog, an elephant, or thelike. In some embodiments, the living animal is a small non-humananimal, e.g., a dog, a cat, a Nigerian pygmy goat, a rodent or the like.

In some embodiments, the selectively controlling the light signalsincludes controlling a pulse width of the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling a duty cycle of the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling an on-time and an off-time of the plurality oflight signals.

In some embodiments, the selectively controlling the light signalsincludes controlling a wavelength of the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling a pulse repetition rate of the plurality of lightsignals.

In some embodiments, the selectively controlling the light signalsincludes controlling a pulse shape of the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling a minimum light intensity and a maximum lightintensity of the plurality of light signals.

In some embodiments, the present invention provides a combination ofelectrical stimulation signals and optical stimulation signals,optionally delivered using electro-optical combination fibers and probessuch as described in U.S. patent application Ser. No. 12/018,185 filedJan. 22, 2008, titled “Hybrid Optical-Electrical Probes” (now U.S. Pat.No. 7,883,536 issued Feb. 8, 2011, Attorney Docket No. 5032.027US1), andoptionally including combination electro-optical stimulation signalssuch as described in U.S. patent application Ser. No. 12/573,848 filedOct. 5, 2009, titled “Nerve Stimulator and Method using SimultaneousElectrical and Optical Signals” (Attorney Docket 5032.045US1). In someembodiments, the optical-stimulation light signals are selectivelycontrolled to initiate or increase the rate of NAP triggering, while inother embodiments, the optical-stimulation light signals are selectivelycontrolled to stop or decrease the rate of NAP triggering. In someembodiments, the selectively controlling the light signals includescontrolling a DC background amount of light intensity of the pluralityof light signals. In some embodiments, the stimulation signals include aplurality of signals substantially simultaneously emitted from aplurality of emitters that are all sub-threshold by themselves but whichadd to a threshold amount of light at the intersection of the lightbeams. In some embodiments, even at the intersection of the plurality oflight beams, the amount of light is sub-threshold with regard totriggering a NAP when applied without a co-occurring electricalstimulation pulse (e.g., wherein the electrical pulse, if applied alone,is also sub-threshold with regard to triggering a NAP), but when theplurality of beams intersects at a nerve that is in the vicinity of theelectrical signal, the combination of the plurality of sub-thresholdlight beams and the sub-threshold electrical signal is sufficient totrigger a NAP.

In some embodiments, the present invention provides a combination ofelectrical and optical stimulation. In some embodiments, the methodfurther includes selectively controlling and applying to one or moretissues of the animal one or more electrical signals (i.e., hybridelectrical and optical stimulation of one or more tissues). In someembodiments, the selectively controlling and applying the electricalsignal(s) includes controlling and applying a DC background amount ofelectrical signal. In some embodiments, the selectively controlling andapplying the electrical signal(s) includes applying electrical pulses.

In some embodiments, the selectively controlling the light signalsincludes controlling a precharge amount of light intensity followed by atrigger amount of light intensity of the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling the light signals to delay at least some of theNAPs produced by the one or more nerves that would otherwise occurwithout the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling the light signals to increase a frequency of theNAPs produced by the one or more nerves that would otherwise occurwithout the plurality of light signals.

In some embodiments, the selectively controlling the light signalsincludes controlling the light signals to decrease a frequency of theNAPs produced by the one or more nerves that would otherwise occurwithout the plurality of light signals.

In some embodiments, the obtaining the plurality of light signalsincludes implanting a self-contained battery-poweredlaser-light-generation device.

In some embodiments, the plurality of light signals includes implantingself-contained infrared (IR) laser device.

In some embodiments, the delivering the plurality of light signals toone or more nerves of the PNS and/or the CNS includes using one or moreoptical fibers to guide the light signals.

In some embodiments, the delivering the plurality of light signals toone or more nerves of the PNS and/or the CNS includes positioning adelivery end of one or more fibers against a vestibular organ and usingthe one or more optical fibers to guide the light signals from a lasersource to the vestibular organ.

In some embodiments, the one or more laser light sources include a firstlight source and a second light source, wherein the selectivelycontrolling the plurality of light signals includes controlling thefirst light source to send a first series of pulses during a firstperiod of time and controlling the second light source to send a secondseries of pulses during the first period of time, and wherein the firstseries of pulses differs from the second series of pulses in repetitionrate.

In some embodiments, electrical stimulation delivered via nervesconnected to muscles is sensed. In some embodiments, the result of themuscular movement is sensed.

In some embodiments of the invention, monitoring muscular stimulationincludes monitoring eye movements.

In some embodiments, electrical stimulation delivered via nervesconnected to eye muscles is sensed. In some embodiments, the eyemovement is sensed to indirectly sense eye muscle stimulation.

In some embodiments, the present invention provides an apparatus thatincludes one or more laser light sources configured to generate aplurality of light signals; and a transmission medium configured totransmit the plurality of light signals from the one or more laser lightsources to one or more nerves of the PNS and/or the CNS of a livinganimal; a controller to selectively control the plurality of lightsignals from each of the one or more infrared-laser light sources suchthat the light signals provide controlled optical stimulation to the oneor more nerves in order to control nerve action potentials (NAPs)produced by the one or more nerves.

In some embodiments, the living animal is a human person. In someembodiments, the living animal is a large non-human animal, e.g., a racehorse or dairy cow. In some embodiments, the living animal is a smallnon-human animal, e.g., a dog or cat.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a pulse width of the pluralityof light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a duty cycle of the pluralityof light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of an on-time and an off-time ofthe plurality of light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a wavelength of the pluralityof light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a pulse repetition rate of theplurality of light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a pulse shape of the pluralityof light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a minimum light intensity and amaximum light intensity of the plurality of light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a DC background amount of lightintensity of the plurality of light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of a precharge amount of lightintensity followed by a trigger amount of light intensity amount oflight intensity of the plurality of light signals.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of the plurality of light signalsto delay at least some of the NAPs produced by the one or more nervesthat would otherwise occur.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of the plurality of light signalsto increase a frequency of the NAPs produced by the one or more nervesthat would otherwise occur.

In some embodiments, the control of the light signals provided by thecontroller includes selective control of the plurality of light signalsto decrease a frequency of the NAPs produced by the one or more nervesthat would otherwise occur.

In some embodiments, the apparatus includes an implanted aself-contained battery-powered laser light-generation device.

In some embodiments, the obtaining the plurality of light signalsincludes implanting self-contained infrared (IR) laser device.

In some embodiments, the a transmission medium configured to transmitlight signals from the one or more laser light sources to one or morenerves of the PNS and/or the CNS of a living animal includes one or moreoptical fibers configured to guide the light signals.

In some embodiments, the one or more laser light sources include a firstlight source and a second light source, wherein the control of the lightsignals provided by the controller includes selective control of thefirst light source to send a first series of pulses during a firstperiod of time and selective control of the second light source to senda second series of pulses during the first period of time, and whereinthe first series of pulses differs from the second series of pulses inrepetition rate.

In some embodiments, the present invention provides an apparatus furtherincluding at least one sensor configured to sense one or more conditionsthat affect balance, and wherein the control of the light signalsprovided by the controller includes selective control of the lightsignals to provide a sense-of-balance nerve stimulation at least partlybased on a signal from the at least one sensor.

In some embodiments, the at least one sensor includes a motion sensor.

In some embodiments, the at least one sensor includes an orientationsensor.

In some embodiments, the at least one sensor includes a muscularstimulation monitor.

In some embodiments, electrical stimulation carried via efferent nervesto muscles is sensed. In some embodiments, the result of the muscularmovement is sensed.

In some embodiments, the muscular stimulation monitor includes a sensorthat monitors eye movements.

In some embodiments, the present invention provides an apparatus thatincludes means for obtaining a plurality of light signals from one ormore laser light sources; means for delivering the plurality of lightsignals to one or more nerve pathways of the PNS and/or the CNS of aliving animal; and means for selectively controlling the plurality oflight signals to optically stimulate the one or more nerves in order tocontrol nerve action potentials (NAPs) or compound nerve-actionpotentials (CNAPs) produced in the one or more nerve pathways.

In some embodiments, the living animal is a human person. In someembodiments, the living animal is a large non-human animal, e.g., a racehorse or dairy cow. In some embodiments, the living animal is a smallnon-human animal, e.g., a dog or cat.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a pulse width of the plurality oflight signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a duty cycle of the plurality oflight signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling an on-time and an off-time of theplurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a wavelength of the plurality oflight signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a pulse repetition rate of theplurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a pulse shape of the plurality oflight signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a minimum light intensity and amaximum light intensity of the plurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a DC background amount of lightintensity of the plurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling a precharge amount of lightintensity followed by a trigger amount of light intensity of theplurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling the light signals to delay atleast some of the NAPs produced by the one or more nerves that wouldotherwise occur without the plurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling the light signals to increase afrequency of the NAPs produced by the one or more nerves that wouldotherwise occur without the plurality of light signals.

In some embodiments, the means for selectively controlling the lightsignals includes means for controlling the light signals to decrease afrequency of the NAPs produced by the one or more nerves that wouldotherwise occur without the plurality of light signals.

In some embodiments, the means for obtaining the plurality of lightsignals includes implanting a self-contained battery-poweredlaser-light-generation device.

In some embodiments, the obtaining the plurality of light signalsincludes implanting self-contained infrared (IR) laser device.

In some embodiments, the means for delivering the plurality of lightsignals to one or more nerves of the PNS and/or the CNS includes usingone or more optical fibers to guide the light signals.

In some embodiments, the one or more laser light sources include a firstlight source and a second light source, wherein the means forselectively controlling the plurality of light signals includes meansfor controlling the first light source to send a first series of pulsesduring a first period of time and means for controlling the second lightsource to send a second series of pulses during the first period oftime, and wherein the first series of pulses differs from the secondseries of pulses in repetition rate.

In some embodiments, the means for sensing the one or more conditionsthat affect balance includes means for monitoring muscular stimulation.

In some embodiments, electrical stimulation delivered via nervesconnected to muscles is sensed. In some embodiments, the result of themuscular movement is sensed.

In some embodiments, the means for monitoring muscular stimulationincludes means for monitoring eye movements.

In some embodiments, electrical stimulation delivered via nervesconnected to eye muscles is sensed. In some embodiments, the eyemovement is sensed to indirectly sense eye muscle stimulation.

In some embodiments, electrical stimulation to eye muscles is sensed. Insome embodiments, the eye movement is sensed to indirectly sense eyemuscle stimulation.

In some embodiments, the present invention provides a method thatincludes obtaining light from an optical source; and transmitting thelight to respective nerves the PNS and/or the CNS of an animal. Theanimal can either be a human or be some other animal.

In some embodiments, the transmitting includes transmitting differentwavelengths of the light to stimulate respective nerves the PNS and/orthe CNS.

In some embodiments, various parameters are adjusted and/or controlled,such as the pulse repetition rate or pattern, the pulse width, the pulseintensity, the wavelength(s), the amount of background constant (DC)optical level, and/or selected multiple simultaneous wavelengths.Multiple wavelengths are provided, in some embodiments, by using aplurality of lasers having different wavelengths. In some embodiments, aplurality of fibers is used to deliver the stimulation light to aplurality of stimulation sites.

In some embodiments, the present invention includes triggers and sensorsthat generate signals that are input to software of the presentinvention, wherein the software analyzes the signals and based on theanalysis, generates control signals that control the parameters, such asfrequency and intensity of light output (e.g., laser pulses) for each ofone or more channels that communicate with the vestibular nucleus. Forexample, some embodiments use sensors such as described in U.S. Pat. No.6,546,291 issued to Merfeld et al. on Apr. 8, 2003, which was describedabove and which is incorporated herein by reference. For example, someembodiments include sensors for detecting characteristics of thepatient's head, eyes, posture and the like.

Some embodiments use one or more implanted VCSEL arrays to directlystimulate the desired nerves, while in other embodiments, one or moreimplanted VCSELs are optically coupled using one or more optical fibersleading to the stimulation sites.

In other embodiments, one or more VCSEL arrays are located external tothe patient's body and use transcutaneous coupling to one or moreimplanted fiber arrays. In some embodiments, the implanted fiber arraysprovide one or more feedback loops (e.g., a fiber having both of itsends facing outwards from the body) in order to assist couplingalignment. In some embodiments, permanent magnets are used on theimplanted fiber arrays and external VCSEL stimulator to maintaincoupling and assist in coupling alignment. In some embodiments, theimplanted fiber arrays have a bulbous head on each fiber to collect anddirect laser light into the fiber core.

Some embodiments provide programmable and/or reprogrammable control. Insome embodiments, the controller is implanted in the body, and in someother embodiments, the controller is located external to the body andcoupled to an implanted fiber array using transcutaneous coupling (e.g.,some embodiments use a VCSEL array to provide light from the stimulator.

In some embodiments, electrical signals of the nerves are sensed andused to provide feedback to the controller, in order to better controlthe laser stimulation signal.

In some embodiments, the obtaining light includes implanting aself-contained infrared laser device.

In some embodiments, the obtaining light includes implanting aself-contained battery-powered device.

In other embodiments, the present invention provides an apparatus thatincludes an optical source; and a transmission medium configured totransmit light from the optical source to respective nerves of the PNSand/or the CNS of an animal.

In some embodiments, the transmission medium includes a plurality ofoptical fibers, and the optical source couples different amounts of thelight through the plurality of optical fibers to stimulate differentrespective nerves of each of the PNS and/or the CNS.

In some embodiments, the optical source couples different wavelengths ofthe light to stimulate different respective nerves of each of the PNSand/or the CNS.

In some embodiments, the optical source includes a self-containedimplantable infrared laser device.

In some embodiments, the optical source includes a self-containedbattery-powered device.

In other embodiments, the present invention provides an apparatus thatincludes means for obtaining light from an optical source; and means fortransmitting the light to respective nerves of the PNS and/or the CNS.

In some embodiments of the apparatus, the means for transmittingincludes means for transmitting different amounts of the light throughoptical fibers to stimulate respective nerves of the PNS and/or the CNS.In some embodiments, the means for transmitting includes means fortransmitting different wavelengths of the light to stimulate respectivenerves of the PNS and/or the CNS. In some embodiments, the means forobtaining light includes a self-contained infrared laser implantabledevice. In some embodiments, the means for obtaining light includes aself-contained battery-powered implantable device.

SOME RELEVANT PUBLICATIONS ARE THE FOLLOWING

-   Shannon R V, Otto S R.; Psychophysical measures from electrical    stimulation of the human cochlear nucleus, Hear. Res., 1990 Aug. 1;    47(1-2):159-68.-   Otto S R, House W E, Brickman D E, Heidelberger W E, Nelson R A.;    Auditory brain stem implant: effect of tumor size and preoperative    hearing level on function, Ann. Otol. Rhinol. Laryngeal., 1990    October; 99(10 Pt 1):789-90.-   Liu X, McPhee G, Seldon H L, Clark G M.; Histological and    physiological effects of the central auditory prosthesis: surface    versus penetrating electrodes, Hear, Res. 1997 December;    114(1-2):264-74.-   Lenarz T, Lim H H, Reuter G, Patrick J F, Lenarz M.; The auditory    midbrain implant: a new auditory prosthesis for neural    deafness-concept and device description, Otol. Neurotol. 2006    September; 27(6):838-43. Review.-   Samii A, Lenarz M, Majdani O, Lim H H, Samii M, Lenarz T.; Auditory    midbrain implant: a combined approach for vestibular schwannoma    surgery and device implantation. Otol. Neurotol. 2007 January;    28(1):31-8.

SOME ADVANTAGES OF THE INVENTION OVER FORMER METHODS

In some embodiments, an advantage of optical stimulation of the nervesof the PNS and/or the CNS is the greater selectivity of neuronalactivation using radiant energy compared with electrical stimulationwherein only neurons in the path of the laser light are activated. Insome embodiments, the present invention provides optical-electrodehybrid designs that are able to use many more channels than electricallybased systems, where channel crosstalk becomes a problem when using moreelectrodes spaced closely together. This has implications for all nervesof the PNS and the CNS. In some embodiments, the greater precisionprovided by using optical stimulation of the nerve and/or nerve bundleallows for more precise selective activation of particular neurons andminimizes the nonspecific stimulation of surrounding neurons.

A group from Vanderbilt University has described infrared laserstimulation in rat-brain slices (not in vivo) in aconference-proceedings publication, but this was not a peer-reviewedpublication: Cayce, J M; Kao, C C; Mahadevan, G; Malphurus, J D; Konrad,P E; Jansen, E D; and Mahadevan-Jansen, A. Optical stimulation of ratthalamocortical brain slices. SPIE Proceedings January 2008, San Jose,Calif.

In some embodiments, the present invention provides a method forstimulating neurons of the PNS and/or the CNS of a patient to providesensations for the patient. This method includes generating a pluralityof light signals that, when applied to a neuron of a person, canstimulate a nerve action potential in the neuron; delivering the lightsignals to one or a plurality of neurons of the brainstem or midbrain ofthe patient; and selectively controlling the plurality of light signalsto optically stimulate the one or more neurons in order to control nerveaction potentials (NAPs) produced by the plurality of neurons.

Some embodiments of the method further include receiving image data; andprocessing the received image data to obtain vision information, whereinthe delivering of light signals comprises delivering the light pulses toa vision portion of the brainstem or midbrain of the patient.

In some embodiments of the method, the delivering of light signalsfurther includes delivering infrared light from a laser.

In some embodiments of the method, the delivering of light signalsfurther includes delivering infrared light from a vertical-cavitysurface-emitting laser (VCSEL).

In some embodiments of the method, the delivering of light signalsfurther includes delivering the light signals to peripheral projectionsof the neurons.

In some embodiments of the method, the delivering of light signalsfurther includes delivering the light signals to central portions of theneurons.

In some embodiments of the method, the delivering of the light signalsfurther includes obtaining a plurality of light signals from one or morelaser light sources and delivering the obtained light signals todiscrete portions of excitable tissues, said signals being interpretableby the patient's brain as sensory responses.

In some embodiments of the method, the delivering of the light signalsfurther includes selectively controlling the light signals to opticallystimulate the one or more neurons in order to control nerve actionpotentials (NAPs) produced by the one or more neurons. In someembodiments of the method, the selectively controlling the light signalsfurther includes controlling a pulse width of the plurality of lightsignals. In some embodiments of the method, the selectively controllingthe light signals further includes controlling a pulse repetition rateof the plurality of light signals. In some embodiments of the method,the selectively controlling the light signals further includescontrolling a pulse shape of the plurality of light signals. In someembodiments of the method, the selectively controlling the light signalsfurther includes controlling a DC background amount of light intensityof the plurality of light signals. In some embodiments of the method,the selectively controlling the light signals further includescontrolling a precharge amount of light intensity followed by a triggeramount of light intensity of the plurality of light signals. In someembodiments of the method, the selectively controlling the light signalsfurther includes controlling the light signals to increase a frequencyof the NAPs produced by the one or more neurons that would otherwiseoccur without the plurality of light signals.

In some embodiments of the method, the obtaining of the plurality oflight signals further includes implanting a self-containedbattery-powered laser-light-generation device.

In some embodiments of the method, the delivering of the light signalsto the plurality of neurons of the brainstem or midbrain of the patientincludes positioning a delivery end of a plurality of optical fibers ina probe end placed against the brainstem or midbrain of the patient andusing the plurality of optical fibers to guide the light signals from alaser source to the brainstem or midbrain of the patient.

In some embodiments of the method, the generating of the light signalsincludes providing a first laser source and a second laser source,wherein the selectively controlling the plurality of light signalsincludes controlling the first laser source to send a first series ofpulses during a first period of time and controlling the second lasersource to send a second series of pulses during the first period oftime, and wherein the first series of pulses differs from the secondseries of pulses in repetition rate. In some embodiments of the method,the sensing of the one or more conditions that affect balance includesmonitoring eye movements.

In some embodiments, the present invention provides an apparatus thatincludes one or more light sources that are configured to generate aplurality of light signals; a transmission medium configured to transmitthe plurality of light signals from the one or more light sources to aplurality of neurons of a nerve in the PNS and/or the CNS of a livinganimal to provide sensations for the living animal; and a controlleroperatively coupled to the one or more light sources to selectivelycontrol the plurality of light signals from each of the one or morelight sources such that the light signals provide controlled opticalstimulation to the plurality of neurons in order to control nerve actionpotentials (NAPs) produced by the plurality of neurons.

In some embodiments of the apparatus, control of the light signalsprovided by the controller includes selective control of a duty cycle ofthe plurality of light signals.

In some embodiments of the apparatus, the control of the light signalsprovided by the controller includes selective control of a wavelength ofthe plurality of light signals.

In some embodiments of the apparatus, the transmission medium includes aplurality of data channels (i.e., input and/or output channels (called“I/Os”)). In some embodiments, the transmission medium includes aplurality of optical fibers, each having a conductive material (e.g., ametal film) applied to a surface of the optical fiber, wherein theconductive material is in turn covered with an insulator (e.g., apolymer coating, and/or a silicon oxide and/or silicon nitride insulatorlayer), and optionally one or more additional conductive layers furthercoated by additional insulator layers to provide a coaxially shieldedelectrical conductor that is formed directly on the optical fiber, andwherein the optical fiber is used to deliver the optical stimulationpulses and the one or more electrical conductors are used to transmitelectrical stimulation or pre-conditioning electrical energy to thetissue being stimulated. In some embodiments, the electrical conductorsare also used to carry electrical signals sensed from the neurons of thepatient (e.g., NAP signals in the nerve pathways are detectedelectrically using the conductors formed on the optical fibers). In someembodiments, each of a plurality of the optical fibers have a metalliccoating that has an insulator formed over the metallic coating, and abundle of such fibers deliver a plurality of different optical signals(e.g., the optical-stimulation pulses are individually controlled) inparallel and a plurality of different stimulation electrical signals(e.g., the electrical-stimulation or -preconditioning pulses areindividually controlled) in parallel such that different areas of nerveof the PNS and/or the CNS of the patient are stimulated in differentmanners

In some embodiments of the apparatus, the transmission medium includes aplurality of optical fibers each of which carries a different signal. Insome such embodiments, the plurality of optical fibers each have one ormore electrical conductors formed thereon, wherein each of a pluralityof the electrical conductors carry a different signal.

In some embodiments of the apparatus, the transmission medium includesan optical fiber. In some embodiments of the apparatus, the transmissionmedium includes a lens. In some embodiments of the apparatus, thetransmission medium delivers the light signals from the one or morelight sources without using an optical fiber or a lens. In someembodiments of the apparatus, the transmission medium includes otherlight-transmitting materials such as quartz, fused silica, silicon, InP,GaP, and the like, made in light-guiding shapes such as an array of, orother configuration having one or more, individual rods, cones,pyramids, and the like, the end(s) of which shapes are, in variousembodiments, shaped with domes, lenses, gratings, chamfers, curvedwaveguides, and the like, for light-shaping and pointing purposes.

Some embodiments of the apparatus further includes a sensor (e.g.,light, pressure, temperature, sound, or the like) having a signal outputoperatively coupled to a wireless transmitter that is configured totransmit information based on the sensor signal to the controller.

In some embodiments of the apparatus, the sensor further includes aprocessor that is configured to receive a stimulus response signal andbased on the signal to generate information used by the controller togenerate stimulation pulses configured to be interpretable by the livinganimal's brain in order to encode understanding of the stimulus responsesignal.

In some embodiments of the apparatus, the one or more light sourcesfurther include one or more lasers. In some embodiments of theapparatus, the one or more light sources further include at least onetunable laser. In some embodiments of the apparatus, the one or morelasers output an infrared signal having a wavelength between about onemicron and about five microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength in a range of between about one micron and about two microns(the range inclusive). In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about1.8 microns and about 1.9 microns.

In some other embodiments of the apparatus, the one or more lasersoutput an infrared signal having a wavelength between about 0.7 micronsand about 0.8 microns, inclusive. In some embodiments of the apparatus,the one or more lasers output an ultraviolet signal having a wavelengthbetween about 0.1 microns and about 0.4 microns, inclusive. In someembodiments of the apparatus, the one or more lasers output a visiblesignal having a wavelength between about 0.4 microns and about 0.7microns, inclusive. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about0.8 microns and about 0.9 microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength between about 0.9 microns and about 1.0 microns, inclusive.In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength between about 1.0 microns and about1.1 microns, inclusive. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about1.1 microns and about 1.2 microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength between about 1.2 microns and about 1.3 microns, inclusive.In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength between about 1.3 microns and about1.4 microns, inclusive. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about1.4 microns and about 1.5 microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength between about 1.5 microns and about 1.6 microns, inclusive.In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength between about 1.6 microns and about1.7 microns, inclusive. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about1.7 microns and about 1.8 microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength between about 1.9 microns and about 2.0 microns, inclusive.In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength between about 2.0 microns and about2.1 microns, inclusive. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about2.1 microns and about 2.3 microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength between about 2.3 microns and about 2.5 microns, inclusive.In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength between about 2.5 microns and about3 microns, inclusive. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a wavelength between about3 microns and about 5 microns, inclusive. In some embodiments of theapparatus, the one or more lasers output an infrared signal having awavelength between about 5 microns and about 10 microns, inclusive. Insome embodiments, the lasers output an optical signal having two or morewavelengths in one or more of the above-listed ranges. In someembodiments, a first subset (e.g., blue light) of two or morewavelengths is selectively transmitted to activate neurons, while asecond subset of wavelengths (e.g., yellow light) is selectivelytransmitted to deactivate neurons (such as described in the above-citedpaper by Bernstein, Jacob G., et al. titled “Prosthetic systems fortherapeutic optical activation and silencing of genetically-targetedneurons” that describes that two naturally-occurring light-activatedproteins channelrhodopsin-2 (ChR2) and halorhodopsin (Halo/NpHR) can,when genetically expressed in neurons, enable them to be safely,precisely, and reversibly activated and silenced by pulses of blue andyellow light, respectively, wherein in some embodiments, the two (ormore) light-activated proteins are virally or transgenically deliveredinto the desired neurons to transform such neurons into what we calloptogenetically active neurons).

In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength of about 1540 nanometers (1.54microns). In some embodiments of the apparatus, the one or more lasersoutput an infrared signal having a wavelength of about 1800 nanometers.In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a wavelength of about 1849 nanometers. In someembodiments of the apparatus, the one or more lasers output an infraredsignal having a wavelength of 1849 nanometers.

In some embodiments, the present invention further includes applying aprecharge amount of stimulation electrical current to the neuronaltissue of the patient that is to be stimulated (e.g., to a plurality ofnerve pathways the brainstem or midbrain of the patient), which is thenfollowed by a trigger amount of pulsed light intensity of the pluralityof light signals.

In some embodiments, the nerve stimulation includes an electricalcurrent of about 0.1 mA to about 10 mA, plus an optical energy of about0.01 J/cm² to about 1 J/cm². In some embodiments, the stimulationincludes an electrical current of about 0.01 mA to about 0.02 mA betweenclosely spaced electrodes (in some embodiments, the closely spacedelectrodes include a metallization layer on each of two optical fibersthat are both in one fiber-optic bundle; while in other embodiments, theclosely spaced electrodes include separated portions of a metallizationlayer on a single optical fiber (e.g., wherein the metallization hasbeen etched into a plurality of separate longitudinal conductors, and,in some embodiments, wherein the etching is helical around the opticalfiber such that a twisted pair of conductors (or a plurality of suchpairs) is formed, while in other embodiments, coaxial metallizationlayers are formed using an insulating layer to separate each pair ofconduction layers). A current is sent through the separate conductors onthe optical fiber and thus through the tissue that is adjacent to thelight-emitting end of the optical-fiber waveguide such that theelectrical field and the optical radiation are self aligned with oneanother. In some embodiments, the stimulation includes an electricalcurrent of about 0.02 mA to about 0.05 mA between closely spacedelectrodes. In some embodiments, the stimulation includes an electricalcurrent of about 0.025 mA to about 0.035 mA between closely spacedelectrodes. In some embodiments, the stimulation includes an electricalcurrent of about 0.035 mA to about 0.05 mA between closely spacedelectrodes. In some embodiments, the stimulation includes an electricalcurrent of about 0.025 mA between closely spaced electrodes. In someembodiments, the stimulation includes an electrical current of about0.035 mA between closely spaced electrodes. In some embodiments, thestimulation includes an electrical current of about 0.05 mA betweenclosely spaced electrodes. In some embodiments, the stimulation includesan electrical current of about 0.1 mA between closely spaced electrodes.In some embodiments, the stimulation includes an electrical current ofabout 0.05 mA to about 0.1 mA between closely spaced electrodes. In someembodiments, the stimulation includes an electrical current of about 0.1mA to about 0.2 mA between closely spaced electrodes. In someembodiments, the stimulation includes an electrical current of about 0.2mA to about 0.5 mA between closely spaced electrodes. In someembodiments, the stimulation includes an electrical current of about 0.5mA to about 1 mA between closely spaced electrodes. In some embodiments,the stimulation includes an electrical current of about 1 mA to about 2mA between closely spaced electrodes. In some embodiments, thestimulation includes an electrical current of about 2 mA to about 5 mAbetween closely spaced electrodes. In some embodiments, the stimulationincludes an electrical current of about 5 mA to about 10 mA betweenclosely spaced electrodes.

In some embodiments, the pulse repetition rate of the optical signal isabout 1 to 2 pulses per second. In some embodiments, the pulserepetition rate of the optical signal is about 2 to 5 pulses per second.In some embodiments, the pulse repetition rate of the optical signal isabout 5 to 10 pulses per second. In some embodiments, the pulserepetition rate of the optical signal is about 10 to 20 pulses persecond. In some embodiments, the pulse repetition rate of the opticalsignal is about 20 to 50 pulses per second. In some embodiments, thepulse repetition rate of the optical signal is about 50 to 100 pulsesper second. In some embodiments, the pulse repetition rate of theoptical signal is about 100 to 200 pulses per second. In someembodiments, the pulse repetition rate of the optical signal is about200 to 500 pulses per second. In some embodiments, the pulse repetitionrate of the optical signal is about 500 to 1000 pulses per second. Insome embodiments, the pulse repetition rate of the optical signal isabout 1000 to 2000 pulses per second. In some embodiments, the pulserepetition rate of the optical signal is more than about 2000 pulses persecond.

In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a radiant exposure of no more than 4 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of no more than 3 J/cm² per nerve-action-potentialresponse generated. In some embodiments of the apparatus, the one ormore lasers output an infrared signal having a radiant exposure of nomore than 2 J/cm² per nerve-action-potential response generated.

In some embodiments of the apparatus, the one or more lasers output aninfrared signal having a radiant exposure of between about 5 J/cm² andabout 6 J/cm² per nerve-action-potential response generated. In someembodiments of the apparatus, the one or more lasers output an infraredsignal having a radiant exposure of between about 4 J/cm² and about 4J/cm² per nerve-action-potential response generated. In some embodimentsof the apparatus, the one or more lasers output an infrared signalhaving a radiant exposure of between about 3 J/cm² and about 4 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 3 J/cm² and about 3.5 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 2.5 J/cm² and about 3 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 2 J/cm² and about 2.5 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 1.5 J/cm² and about 2 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 1 J/cm² and about 1.5 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 0.5 J/cm² and about 1 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 0.2 J/cm² and about 0.5 J/cm² pernerve-action-potential response generated. In some embodiments of theapparatus, the one or more lasers output an infrared signal having aradiant exposure of between about 0.1 J/cm² and about 0.2 J/cm² pernerve-action-potential response generated.

In some embodiments, the one or more lasers output an infrared signalhaving and energy of less than about 2 mJ per pulse.

In some embodiments, the one or more lasers output an infrared signalhaving a pulse width of between about ten microseconds (10 μs) and aboutfive milliseconds (5 ms).

In some embodiments, the one or more lasers output an infrared signalhaving a pulse width of between about 1 μs and about 10 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 10 μs and about 20 μs. In some embodiments,the one or more lasers output an infrared signal having a pulse width ofbetween about 20 μs and about 50 μs. In some embodiments, the one ormore lasers output an infrared signal having a pulse width of betweenabout 20 μs and about 40 μs. In some embodiments, the one or more lasersoutput an infrared signal having a pulse width of between about 40 μsand about 80 μs. In some embodiments, the one or more lasers output aninfrared signal having a pulse width of between about 80 μs and about160 μs. In some embodiments, the one or more lasers output an infraredsignal having a pulse width of between about 50 μs and about 100 μs. Insome embodiments, the one or more lasers output an infrared signalhaving a pulse width of between about 100 μs and about 200 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 200 μs and about 500 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 200 μs and about 400 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 400 μs and about 800 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 800 μs and about 1600 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 500 μs and about 1000 μs. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 1 millisecond (ms) and about 2 ms. In someembodiments, the one or more lasers output an infrared signal having apulse width of between about 2 ms and about 5 ms. In some embodiments,the one or more lasers output an infrared signal having a pulse width ofbetween about 2 ms and about 4 ms. In some embodiments, the one or morelasers output an infrared signal having a pulse width of between about 4ms and about 8 ms. In some embodiments, the one or more lasers output aninfrared signal having a pulse width of between about 8 ms and about 16ms. In some embodiments, the one or more lasers output an infraredsignal having a pulse width of between about 5 ms and about 10 ms.

In some embodiments, the present invention delivers a pulse ofelectrical current to the same site as light pulses. In someembodiments, the electrical pulses are below the threshold for neuralexcitation and the electric field spreads to a larger area than requiredfor the region of interest (the area of specific nerve pathways to bestimulated). The light pulse from the apparatus of the present inventionis delivered to match the exact volume of tissue that is to bestimulated: In some embodiments, the stimulation includes an electricalcurrent of about 0.1 mA to about 10 mA, plus an optical energy of about0.01 J/cm² to about 1 J/cm². Other parameters are determined byempirical experimentation, wherein the pulse repetition rate isgenerally about 10 to 1000 pulses per second.

In some such embodiments, the present invention provides a method thatincludes applying a combination of both an electrical stimulation signaland an optical stimulation signal to trigger a nerve action potential(NAP) in vivo in the brainstem or midbrain of an animal. In someembodiments of this method, the optical stimulation signal is of anature such that if applied alone the optical signal has a lowprobability to trigger a NAP, the probability being no more than 25%. Insome embodiments of this method, the electrical stimulation signal is ofa nature such that if applied alone the electrical signal has a lowprobability to trigger a NAP, the probability being no more than 25%. Insome embodiments of this method, the electrical stimulation signal is ofa nature such that if applied alone the electrical signal has a lowprobability to trigger a NAP, the probability being no more than 25%.Some embodiments of this method further include also selectivelyapplying a visible-indication light signal that indicates a locationthat the optical stimulation signal is to be applied.

Some embodiments of this method further include using a hybrid probehaving an optical fiber inserted an electrically conductive cannula;applying the optical-stimulation signal through the optical fiber; andapplying the electrical-stimulation signal through the cannula. Someembodiments further include delivering a fluid through the cannula toenhance the electrical interface for the electrical-stimulation signaland/or to enhance the optical interface for the optical-stimulationsignal and/or to deliver one or more drugs to the stimulation site. Someembodiments further include withdrawing a fluid through the cannula todiagnose a condition. Some embodiments of this method further includeusing a second probe to obtain an electrical signal representative ofthe triggered NAP. Some embodiments of this method further include thehybrid probe further includes an electrode that is electrically separatefrom the cannula, and the method further includes using the electrode toobtain an electrical response signal representative of the triggeredNAP. Some embodiments of this method further include using the cannulato obtain an electrical response signal representative of the triggeredNAP.

In some embodiments of this method, a signal representative of theelectrical stimulation signal is subtracted from a signal obtained usingthe cannula to obtain the electrical response signal representative ofthe triggered NAP.

Some embodiments of this method further include using a hybrid probehaving an optical fiber that has a metallization layer applied to theoptical fiber; applying the optical-stimulation signal through theoptical fiber; and applying the electrical-stimulation signal throughthe metallization layer. Some embodiments of this method further includeusing a second probe to obtain an electrical response signalrepresentative of the triggered NAP. In some embodiments of this method,the hybrid probe further includes an electrode that is electricallyseparate from the metallization layer, and the method further includesusing the electrode to obtain an electrical response signalrepresentative of the triggered NAP. Some embodiments of this methodfurther include using the metallization layer to obtain an electricalresponse signal representative of the triggered NAP.

In some embodiments, the present invention provides an apparatus thatincludes an electrical-stimulation-signal source configured toselectively output an electrical stimulation signal; anoptical-stimulation-signal source configured to selectively output anoptical stimulation signal; and a controller and delivery mediumoperatively coupled to the electrical-stimulation-signal source and tothe optical-stimulation-signal source and configured to control them anddeliver the optical and electrical signals to trigger a nerve actionpotential (NAP) in vivo in the brainstem or midbrain of an animal.

In some embodiments of this apparatus, the optical stimulation signal isof a nature such that if applied alone the optical stimulation signalhas a low probability to trigger a NAP, the probability being no morethan 25%. In some embodiments of this apparatus, the electricalstimulation signal is of a nature such that if applied alone theelectrical stimulation signal has a low probability to trigger a NAP,the probability being no more than 25%. In some embodiments of thisapparatus, the electrical stimulation signal is of a nature such that ifapplied alone the electrical stimulation signal has a low probability totrigger a NAP, the probability being no more than 25%. In someembodiments of this apparatus, the optical stimulation signal isinfrared, and the apparatus further includes avisible-indication-light-signal source configured to project visiblelight to indicate a location that the optical stimulation signal is tobe applied. Some embodiments of this apparatus further include a hybridprobe having an optical fiber inserted an electrically conductivecannula, wherein the optical-stimulation signal is applied through theoptical fiber and the electrical-stimulation signal is applied throughthe cannula. Some embodiments further include a second probe configuredto obtain an electrical signal representative of the triggered NAP. Insome embodiments, the hybrid probe further includes an electrode that iselectrically separate from the cannula, wherein the electrode isconfigured to obtain an electrical signal representative of thetriggered NAP. In some embodiments, the cannula is used to obtain anelectrical signal representative of the triggered NAP. In some suchembodiments, the apparatus is configured to subtract a signalrepresentative of the electrical stimulation signal from a signalobtained using the cannula to obtain the electrical signalrepresentative of the triggered NAP.

Some embodiments further include a hybrid probe having an optical fiberthat has a metallization layer applied to the optical fiber, wherein theoptical-stimulation signal is applied through the optical fiber and theelectrical-stimulation signal is applied through the metallizationlayer. Some embodiments further include a second probe configured toobtain an electrical signal representative of the triggered NAP. In someembodiments, the hybrid probe further includes an electrode that iselectrically separate from the metallization layer, and is configured toobtain an electrical signal representative of the triggered NAP. In someembodiments, the apparatus is configured to use the metallization layerto obtain an electrical signal representative of the triggered NAP.

In some embodiments, the present invention provides a method thatincludes obtaining a signal (such as an audio signal, a video signal, agravitational orientation, an acceleration signal, a rotation signal, atemperature signal, a pressure signal or the like), and based on thesensed signal applying a combination of both an electrical stimulationsignal and an optical stimulation signal to trigger a nerve actionpotential (NAP) in vivo in the cerebral cortex of an animal.

In some embodiments, the present invention provides an apparatus thatincludes an electrical-stimulation-signal source configured toselectively output an electrical stimulation signal; anoptical-stimulation-signal source configured to selectively output anoptical stimulation signal; and a controller and delivery mediumoperatively coupled to the electrical-stimulation-signal source and tothe optical-stimulation-signal source and configured to control them anddeliver the optical and electrical signals to trigger a nerve actionpotential (NAP) in vivo in the cerebral cortex of an animal.

In some embodiments, the present invention provides a method thatincludes receiving a signal, and based on the received signal applying acombination of both an electrical stimulation signal and an opticalstimulation signal to trigger a nerve action potential (NAP) in vivo inthe spinal cord of an animal.

In some embodiments, the present invention provides a method thatincludes emitting pulsed signal light having a wavelength and having apulse duration from each of a plurality of lasers (for example, laserssuch as vertical cavity surface-emitting lasers (VCSELs) oredge-emitting lasers) including a first laser and a second laser,wherein the lasers are in a device implanted in a patient; directing thesignal light from the first laser onto a first tissue of the patient tostimulate a given physiological response in the first tissue butsubstantially not onto a second tissue; and directing the light from thesecond laser onto the second tissue of the patient to stimulate thesecond tissue but substantially not onto the first tissue. In someembodiments, the signal light has an wavelength between about 0.1microns and about 0.2 microns, inclusive. In some embodiments, thesignal light has an wavelength between about 0.2 microns and about 0.3microns, inclusive. In some embodiments, the signal light has anwavelength between about 0.3 microns and about 0.4 microns, inclusive.In some embodiments, the signal light has a visible wavelength betweenabout 0.4 microns and about 0.45 microns, inclusive. In someembodiments, the signal light has a visible wavelength between about0.45 microns and about 0.5 microns, inclusive. In some embodiments, thesignal light has a visible wavelength between about 0.5 microns andabout 0.55 microns, inclusive. In some embodiments, the signal light hasa visible wavelength between about 0.55 microns and about 0.6 microns,inclusive. In some embodiments, the signal light has a visiblewavelength between about 0.6 microns and about 0.65 microns, inclusive.In some embodiments, the signal light has a visible wavelength betweenabout 0.65 microns and about 0.7 microns, inclusive. In someembodiments, the signal light has a wavelength between about 0.7 micronsand about 0.75 microns, inclusive. In some embodiments, the signal lighthas a wavelength between about 0.75 microns and about 0.8 microns,inclusive. In some embodiments, the signal light has a wavelengthbetween about 0.8 microns and about 0.9 microns, inclusive. In someembodiments, the signal light has a wavelength between about 0.9 micronsand about 1.0 microns, inclusive. In some embodiments, the signal lighthas a wavelength between about 1.0 microns and about 1.1 microns,inclusive. In some embodiments, the signal light has a wavelengthbetween about 1.1 microns and about 1.2 microns, inclusive. In someembodiments, the signal light has a wavelength between about 1.2 micronsand about 1.3 microns, inclusive. In some embodiments, the signal lighthas a wavelength between about 1.3 microns and about 1.4 microns,inclusive. In some embodiments, the signal light has a wavelengthbetween about 1.4 microns and about 1.5 microns, inclusive. In someembodiments, the signal light has a wavelength between about 1.5 micronsand about 1.6 microns, inclusive. In some embodiments, the signal lighthas a wavelength between about 1.6 microns and about 1.7 microns,inclusive. In some embodiments, the signal light has an infraredwavelength between about 1.7 microns and about 1.8 microns, inclusive.In some embodiments, the signal light has an infrared wavelength betweenabout 1.8 microns and about 1.9 microns, inclusive. In some embodiments,the signal light has an infrared wavelength between about 1.9 micronsand about 2 microns, inclusive. In some embodiments, the signal lighthas an infrared wavelength between about 2 microns and about 2.1microns, inclusive. In some embodiments, the signal light has aninfrared wavelength between about 2.1 microns and about 2.3 microns,inclusive. In some embodiments, the signal light has an infraredwavelength between about 2.3 microns and about 2.5 microns, inclusive.In some embodiments, the signal light has an infrared wavelength betweenabout 2.5 microns and about 2.75 microns, inclusive. In someembodiments, the signal light has an infrared wavelength between about2.75 microns and about 3 microns, inclusive. In some embodiments, thesignal light has an infrared wavelength of at least about 3 microns. Insome embodiments, the signal light has two or more wavelengths that arein one or more of the above ranges.

In some embodiments, the present invention provides an apparatus thatincludes an electrical-stimulation-signal source configured toselectively output an electrical-stimulation signal; anoptical-stimulation-signal source configured to selectively output anoptical-stimulation signal; and a controller and delivery mediumoperatively coupled to the electrical-stimulation-signal source and tothe optical-stimulation-signal source and configured to control them anddeliver the optical and electrical signals to trigger a nerve actionpotential (NAP) in vivo in the spinal cord of an animal. In someembodiments, the electrical-stimulation signal and theoptical-stimulation signal are each at a level that is substantiallysub-threshold (i.e., almost all of the time (i.e., at least 90%) theywill not trigger a NAP) if either is applied alone, but when appliedtogether (either simultaneously or sufficiently close to one another intime), the combination of electrical- and optical-stimulation signals issufficient to trigger a NAP (i.e., almost all of the time (i.e., atleast 90%) the combination will trigger a NAP). In some embodiments, theelectrical-stimulation signal and the optical-stimulation signal areeach at a level that is usually sub-threshold (i.e., most of the time(i.e., at least 50%) they will not trigger a NAP) if either is appliedalone, but when applied together (either simultaneously or sufficientlyclose to one another in time), the combination of electrical- andoptical-stimulation signals is usually sufficient to trigger a NAP(i.e., most of the time (i.e., at least 50%) the combination willtrigger a NAP).

In some embodiments, the present invention delivers light pulses fromvertical surface-emitting lasers (VCSELs). In some embodiments,electrical pulses are also delivered at below threshold for neuralexcitation and spread to larger area than required for the region ofinterest (the area to be stimulated). The light pulse is delivered tomatch the exact volume that is to be stimulated: In some embodiments,the electrical energy is about 0.1 mA to about 10 mA plus opticalenergy=0.01-1 J/cm²; Other parameters are determined by empiricalexperimentation, wherein frequency is generally about 10 to 1000 pulsesper second.

In some such embodiments, the present invention provides, in combinationwith others of the other embodiments described herein, one or more ofthe following: a method that includes emitting pulsed light having awavelength in a range of 1.8 microns to 2 microns and having a pulseduration from each of a plurality of vertical cavity surface-emittinglasers (VCSELs) including a first VCSEL and a second VCSEL, directingthe light from the first VCSEL onto a first tissue to stimulate thefirst tissue but substantially not onto a second tissue, and directingthe light from the second VCSEL onto the second tissue to stimulate thesecond tissue but substantially not onto the first tissue; such a methodbut further including emitting pulsed light having a wavelength in arange of 650 nm to 850 nm and having a pulse duration from each of aplurality of vertical cavity surface-emitting lasers (VCSELs) includinga third VCSEL and a fourth VCSEL, directing the light from the thirdVCSEL onto the first tissue and illuminating the first tissue butsubstantially not illuminating the second tissue, detecting a reflectedlight from the first tissue and determining a first physiologicalactivity of the first tissue, directing the light from the fourth VCSELonto the second tissue and illuminating the second tissue butsubstantially not illuminating the first tissue, and detecting areflected light from the second tissue and determining a secondphysiological activity of the second tissue. In some such embodiments,the first VCSEL and the second VCSEL are located on a singlesemiconductor substrate. In some such embodiments, the third VCSEL andthe fourth VCSEL are located on a single semiconductor substrate. Insome such embodiments, the first VCSEL, the second VCSEL, the thirdVCSEL and the fourth VCSEL are located on a single semiconductorsubstrate. Some embodiments further include integrating a firstmicrolens with the first VCSEL and focusing the pulsed light from thefirst VCSEL onto the first tissue, integrating a second microlens withthe second VCSEL and focusing the pulsed light from the second VCSELonto the second tissue, integrating a third microlens with the thirdVCSEL and focusing the pulsed light from the third VCSEL onto the firsttissue, and integrating a fourth microlens with the fourth VCSEL andfocusing the pulsed light from the fourth VCSEL onto the second tissue.Some embodiments further include providing a fiber optic bundleincluding a plurality of optical fibers, integrating a first opticalfiber with the first VCSEL and directing the pulsed light from the firstVCSEL onto the first tissue, integrating a second optical fiber with thesecond VCSEL and directing the pulsed light from the second VCSEL ontothe second tissue, integrating a third optical fiber with the thirdVCSEL and directing the pulsed light from the third VCSEL onto the firsttissue, and integrating a fourth optical fiber with the fourth VCSEL anddirecting the pulsed light from the fourth VCSEL onto the second tissue.In some embodiments, each optical fiber in the plurality of opticalfibers includes a lens. In some embodiments, the first VCSEL and thethird VCSEL are integrated into a first flex-cuff ring and the secondVCSEL and the third VCSEL are integrated into a second flex-cuff ring.In some embodiments, the first VCSEL, the second VCSEL, the third VCSELand the fourth VCSEL are mounted in a biocompatible housing having anoptical feed through.

In some such embodiments, the present invention provides an apparatusthat includes a plurality of vertical cavity surface-emitting lasers(VCSELs) including a first VCSEL and a second VCSEL; a control circuitconfigured to control generation of pulsed light from the first andsecond VCSELs; and a light-delivery system configured to direct thelight from the first VCSEL onto a first tissue but substantially notonto a second tissue in order to stimulate the first tissue; wherein thelight-delivery system is further configured to direct the light from thesecond VCSEL onto the second tissue but substantially not onto the firsttissue in order to stimulate the second tissue. In some embodiments, theapparatus further includes a plurality of vertical cavitysurface-emitting lasers (VCSELs) including a third VCSEL and a fourthVCSEL. The control circuit is further configured to control generationof pulsed light from the third and fourth VCSELs; the light deliverysystem is further configured to direct the light from the third VCSELonto a first tissue but substantially not onto a second tissue in orderto illuminate the first tissue; the light delivery system is furtherconfigured to direct the light from the fourth VCSEL onto the secondtissue but substantially not onto the first tissue in order toilluminate the second tissue; a plurality of detectors including a firstdetector and a second detector; the first detector is configured todetect reflected light from the first tissue to determine a firstphysiological activity in the first tissue; and the second detector isconfigured to detect reflected light from the second tissue to determinea second physiological activity in the second tissue. In someembodiments, the first VCSEL and the second VCSEL are provided on asingle semiconductor substrate. In some embodiments, the third VCSEL andthe fourth VCSEL are provided on a single semiconductor substrate. Insome embodiments, the first VCSEL, the second VCSEL, the third VCSEL andthe fourth VCSEL are provided on a single semiconductor substrate. Insome embodiments, an array of microlenses, integrated on surface of chipis a light-directing structure that directs light from individual VCSELsin a plurality of parallel or different-angled directions. In someembodiments, a plurality of other light-guiding and/or focusing elements(e.g., diffractive surfaces, graded-index fiber sections (called GRINlenses), or other suitable light shaping and/or direction guidingdevices) are fabricated against the VCSEL array. Some embodimentsinclude a first microlens integrated with the first VCSEL to focus thepulsed light from the first VCSEL onto the first tissue; a secondmicrolens integrated with the second VCSEL to focus the pulsed lightfrom the second VCSEL onto the second tissue; a third microlensintegrated with the third VCSEL to focus the pulsed light from the thirdVCSEL onto the first tissue; and a fourth microlens integrated with thefourth VCSEL to focus the pulsed light from the fourth VCSEL onto thesecond tissue. Some embodiments further include a fiber optic bundleincluding a plurality of optical fibers, each optical fiber having afirst end and a second end; a first optical fiber operatively coupled atthe first end of the first optical fiber to the first VCSEL to directthe pulsed light from the first VCSEL through the first optical fiberand the second end of the first optical fiber onto the first tissue; asecond optical fiber operatively coupled at the first end of the secondoptical fiber to the second VCSEL to direct the pulsed light from thesecond VCSEL through the second optical fiber and the second end of thesecond optical fiber onto the second tissue; a third optical fiberoperatively coupled at the first end of the third optical fiber to thethird VCSEL to direct the pulsed light from the third VCSEL through thethird optical fiber and the second end of the third optical fiber ontothe first tissue; and a fourth optical fiber operatively coupled at thefirst end of the fourth optical fiber to the fourth VCSEL to direct thepulsed light from the fourth VCSEL through the fourth optical fiber andthe second end of the fourth optical fiber onto the second tissue. Insome embodiments, each optical fiber in the plurality of optical fibersincludes a lens. In some embodiments, the first VCSEL and the thirdVCSEL are integrated into a first flex-cuff ring and the second VCSELand the third VCSEL are integrated into a second flex-cuff ring. In someembodiments, the first VCSEL, the second VCSEL, the third VCSEL and thefourth VCSEL are mounted in a biocompatible housing having an opticalfeed through.

In some embodiments, each of the embodiments described herein as usingVCSEL arrays (e.g., VCSEL arrays using electrically pumped semiconductordiode structures) instead uses one or more arrays of otherlight-emitting devices (such as light-emitting diodes (LEDs),superluminescent devices, optical-fiber lasers, optically-pumpedsemiconductor lasers (whether or not the laser cavities of such lasersare vertical cavity and surface emitting devices)).

In some embodiments, the present invention provides a method thatincludes selectively emitting a plurality of light signals, each havinga wavelength and each having a pulse duration, from each of a pluralityof vertical cavity surface-emitting lasers (VCSELs) including a firstVCSEL and a second VCSEL; directing the light from the first VCSEL ontoa first tissue of the patient, wherein the light from the first VCSELonto a first tissue of the patient is insufficient alone to stimulate anerve action potential (NAP) in the first tissue; and directing thelight from the second VCSEL onto the first tissue of the patient,wherein the light from the second VCSEL onto a first tissue of thepatient is insufficient alone to stimulate a nerve action potential(NAP) in the first tissue, but wherein the light from the first VCSELand the light from the second VCSEL intersecting onto the first tissueof the patient is sufficient to stimulate a NAP in the first tissue. Insome embodiments, the wavelength directed from the first laser isdifferent than the wavelength directed from the second laser. In someembodiments, the first and second laser signals are emitted from apointy structure that is within the tissue, i.e., the optical-emittingend of the device penetrates the nerve bundle. In some such embodiments,the optical-emitting pointy structure penetrates the peripheral nervebundle radially from the side and at an angle that is substantiallyperpendicular to the longitudinal axis of the peripheral nerve bundle,or that is at an acute angle to the longitudinal axis, or thatpenetrates (for example, in the case of a severed nerve bundle end) froman end of the nerve bundle.

In some embodiments of the method, the plurality of VCSELs are arrangedaround a periphery of the first tissue, and the emitting pulsed lightincludes emitting collimated light inward toward the tissue from thefirst VCSEL and inward toward the tissue from the second VCSEL such thatthe collimated light from the first and second VCSELs intersect atnon-parallel angles.

In some embodiments of the method, the first and second lasers are ondifferent cuffs surrounding a peripheral nerve bundle such that thefirst and second lasers stimulate a single nerve within the peripheralnerve bundle at two longitudinal locations along the nerve.

In some embodiments of the method, the directing the light from thefirst VCSEL and second VCSEL onto the first tissue includes focussingthe pulsed light from the first VCSEL to stimulate the NAP in a firstnerve fiber that is deeper in the first tissue than a second nerve fiberthat is closer to a surface layer in the first tissue adjacent the firstVCSEL without stimulating a NAP in the second nerve fiber.

In some embodiments of the method, the directing of the light from atleast one of the first VCSEL and second VCSEL onto the first tissueincludes using a waveguide with a reflective end that emits light from asidewall of the waveguide.

In some embodiments of the method, the emitting pulsed light from thefirst VCSEL and the second VCSEL includes emitting light of differentwavelengths, a first wavelength of the first laser is different than asecond wavelength of the second laser, and the directing of the lightfrom the first VCSEL and second VCSEL onto the first tissue includesusing waveguides and diffraction gratings.

In some embodiments of the method, the selectively emitting the lightsignals includes varying the pulse duration of at least one of theplurality of light signals, and wherein the selectively emitting thelight signals includes emitting pulsed light substantiallysimultaneously from the first VCSEL and the second VCSEL.

In some embodiments of the method, the selectively emitting the lightsignals includes varying a pulse-repetition rate of the plurality oflight signals.

In some embodiments of the method, the selectively emitting the lightsignals includes selectively varying a pulse temporal intensity shape ofthe plurality of light signals.

In some embodiments of the method, the selectively emitting the lightsignals includes controlling a DC background amount of light intensityof the plurality of light signals.

In some embodiments of the method, the selectively emitting the lightsignals includes controlling a precharge amount of light intensityfollowed by a trigger amount of light intensity of the plurality oflight signals.

In some embodiments of the method, further includes applying a prechargecurrent of electrical energy that is followed by a trigger amount ofpulsed light intensity of the plurality of light signals.

In some embodiments of the method, the wavelength(s) of light from thefirst VCSEL and the wavelength of light from second VCSEL are in a rangeof about 1.8 microns to 2 microns. In some embodiments, the wavelengthis visible to a human eye (e.g., having one or more wavelengths between400 nm and 700 nm). In other embodiments, other wavelengths such asultraviolet (shorter than about 400 nm) or near infrared (e.g., betweenabout 700 nm and about 1800 nm) are used. In other embodiments, farinfrared (e.g., longer than about 2000 nm (out to about 10,000 nm)) areused.

Some embodiments of the method further include a computerized method ofdetermining which of a first plurality of combinations ofnerve-stimulation signals cause a reaction in the patient and storingthat information for future reference and stimulation, wherein each ofthe plurality of combinations of nerve-stimulation signals include aplurality of VCSEL-light signals, wherein the computerized method ofdetermining includes: iteratively applying a plurality of differentcombinations of nerve-stimulation signals to the patient and acquiringdata as to one or more responses that were caused by each combination ofstimulation signals; providing specifications of a plurality of desiredresponses to each of a plurality of conditions; correlating and mappingthe specifications of a plurality of desired responses with the data asto the responses that were caused by each combination of stimulationsignals, and storing a resulting mapping in a computer-readable memory;determining that one of the plurality of conditions has occurred; andbased on the stored mapping and the determination that one of theplurality of conditions has occurred, driving the correspondingcombination of stimulation signals to evoke the desired response to thecondition in the patient.

In some embodiments of the method, the nerve-stimulation signals includean electrical-sensitization signal.

In some embodiments of the method, the plurality of VCSEL-light signalsinclude a plurality of different optical power levels and/or a pluralityof different optical wavelengths

In some embodiments of the method, the determining that one of theplurality of conditions has occurred includes: sensing a firstpatient-physiology parameter, generating a first patient-physiologysignal based on the first patient-physiology parameter, and controllingthe driving of the stimulation signals based on the firstpatient-physiology signal.

In some embodiments of the method, the method further includes detectingan amount of light output onto the first tissue, and using feedbackbased on the detected amount of light to control the intensity orduration of the selectively emitting of the plurality of light signals.In some such embodiments, the detecting of the output optical signal isperformed by obtaining some of the light directly from the emittingdevice, while in other embodiments, the detecting is of light reflectedor diffused from the tissue being stimulated. In some embodiments, oneor more temperature-measuring devices are used to control the feedbackthat controls the light output.

In some embodiments of the method, the determining that one of theplurality of conditions has occurred includes: sensing a firstenvironmental parameter, generating a first environmental signal basedon the first environmental parameter, and controlling the driving of thestimulation signals based on the first environmental signal. In someembodiments, the environmental parameters include one or more of thegroup consisting of heat, pressure, sound, proprioception, patientfeedback, or any other suitable parameter.

Some embodiments of the method further include selectively emittinglight signals having a wavelength in a range of 1.8 microns to 2 micronsand having a pulse duration from a third VCSEL; directing the light fromthe third VCSEL onto the first tissue; and detecting a reflected lightfrom the first tissue and determining a first physiological activity ofthe first tissue.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of vertical cavity surface-emitting lasers (VCSELs)including a first VCSEL and a second VCSEL; a control circuit configuredto control generation of pulsed nerve-stimulation light from the firstand second VCSELs; and a light-delivery system configured to direct thelight from the first VCSEL onto a first tissue of the patient, whereinthe light from the first VCSEL onto a first tissue of the patient isinsufficient alone to stimulate a nerve action potential (NAP) in thefirst tissue, and to direct the light from the second VCSEL onto thefirst tissue of the patient, wherein the light from the second VCSELonto a first tissue of the patient is insufficient alone to stimulate anerve action potential (NAP) in the first tissue, but wherein the lightfrom the first VCSEL and the light from the second VCSEL intersectingonto the first tissue of the patient deliver a trigger amount of pulsedlight sufficient to stimulate a NAP in the first tissue.

Some embodiments of the apparatus further include a control circuitconfigured to control generation of a pre-charge (or sensitizationamount) current of electrical energy that is delivered during a periodof time correlated to (before and/or during) the delivery of the triggeramount of pulsed light intensity of the plurality of light signals.

Some embodiments of the apparatus further include a computer-readablestorage medium, wherein the storage medium includes instructions storedthereon for causing a suitably programmed information processor toexecute a method comprising: determining which of a first plurality ofcombinations of nerve-stimulation signals cause a reaction in thepatient and storing that information for future reference andstimulation, wherein each of the plurality of combinations ofnerve-stimulation signals include a plurality of VCSEL-light signals,wherein the computerized method of determining includes: iterativelyapplying a plurality of different combinations of nerve-stimulationsignals to the patient and acquiring data as to one or more responsesthat were caused by each combination of stimulation signals; providingspecifications of a plurality of desired responses to each of aplurality of conditions; correlating and mapping the specifications of aplurality of desired responses with the data as to the responses thatwere caused by each combination of stimulation signals, and storing aresulting mapping in a computer-readable memory; determining that one ofthe plurality of conditions has occurred; and based on the storedmapping and the determination that one of the plurality of conditionshas occurred, driving the corresponding combination of stimulationsignals to evoke the desired response to the condition in the patient.

In some embodiments, the present invention provides a method thatincludes selectively emitting light signals having a wavelength andhaving a pulse duration from each of a plurality of solid-state lightsources (such as semiconductor lasers (including VCSELs, edge-emittinglasers and quantum-dot lasers, multiple-quantum-well (MQW) lasers andthe like), fiber lasers having semiconductor pump lasers and/ormonolithic-glass-substrate waveguide lasers having semiconductor pumplasers, LEDs, superluminescent emitters and the like) including a firstsolid-state light source and a second solid-state light source;directing the light from the first solid-state light source onto a firsttissue of the patient, wherein the light from the first solid-statelight source onto a first tissue of the patient is insufficient alone tostimulate a nerve action potential (NAP) in the first tissue; anddirecting the light from the second solid-state light source onto thefirst tissue of the patient, wherein the light from the secondsolid-state light source onto a first tissue of the patient isinsufficient alone to stimulate a nerve action potential (NAP) in thefirst tissue, but wherein the light from the first solid-state lightsource and the light from the second solid-state light sourceintersecting onto the first tissue of the patient is sufficient tostimulate a NAP in the first tissue.

In some embodiments, the present invention provides a method thatincludes selectively emitting light signals having a wavelength andhaving a pulse duration from each of a plurality of lasers including afirst laser and a second laser; directing the light from the first laseronto a first tissue of the patient, wherein the light from the firstlaser onto a first tissue of the patient is insufficient alone tostimulate a nerve action potential (NAP) in the first tissue; anddirecting the light from the second laser onto the first tissue of thepatient, wherein the light from the second laser onto a first tissue ofthe patient is insufficient alone to stimulate a nerve action potential(NAP) in the first tissue, but wherein the light from the first laserand the light from the second laser intersecting onto the first tissueof the patient is sufficient to stimulate a NAP in the first tissue.

In some embodiments of the method, the plurality of lasers are arrangedaround a periphery of the first tissue, and the emitting pulsed lightincludes emitting collimated light inward toward the tissue from thefirst laser and inward toward the tissue from the second laser such thatthe collimated light from the first and second lasers intersect atnon-parallel angles.

In some embodiments of the method, the directing the light from thefirst laser and second laser onto the first tissue includes focussingthe pulsed light from the first laser to stimulate the NAP in a firstnerve fiber that is deeper in the first tissue than a second nerve fiberthat is closer to a surface layer in the first tissue adjacent the firstlaser without stimulating a NAP in the second nerve fiber.

In some embodiments of the method, the directing of the light from atleast one of the first laser and second laser onto the first tissueincludes using a waveguide with a reflective end that emits light from asidewall of the waveguide.

In some embodiments of the method, the emitting pulsed light from thefirst laser and the second laser includes emitting light of differentwavelengths, and the directing the light from the first laser and secondlaser onto the first tissue includes using waveguides and diffractiongratings.

In some embodiments of the method, the selectively emitting the lightsignals includes varying the pulse duration of at least one of theplurality of light signals, and wherein the selectively emitting thelight signals includes emitting pulsed light substantiallysimultaneously from the first laser and the second laser.

In some embodiments of the method, the selectively emitting the lightsignals includes varying a pulse-repetition rate of the plurality oflight signals.

In some embodiments of the method, the selectively emitting the lightsignals includes selectively varying a pulse shape of the plurality oflight signals.

In some embodiments of the method, the selectively emitting the lightsignals includes controlling a non-pulsed background amount of lightintensity of the plurality of light signals.

In some embodiments of the method, the selectively emitting the lightsignals includes controlling a precharge amount of light intensityfollowed by a trigger amount of light intensity of the plurality oflight signals.

In some embodiments of the method, further includes applying a prechargecurrent of electrical energy that is followed by a trigger amount ofpulsed light intensity of the plurality of light signals.

In some embodiments of the method, the wavelength of light from thefirst laser and the wavelength of light from second laser are in a rangeof about 1.8 microns to 2 microns.

Some embodiments of the method further include a computerized method ofdetermining which of a first plurality of combinations ofnerve-stimulation signals cause a reaction in the patient and storingthat information for future reference and stimulation, wherein each ofthe plurality of combinations of nerve-stimulation signals include aplurality of laser-light signals, wherein the computerized method ofdetermining includes: iteratively applying a plurality of differentcombinations of nerve-stimulation signals to the patient and acquiringdata as to one or more responses that were caused by each combination ofstimulation signals; providing specifications of a plurality of desiredresponses to each of a plurality of conditions; correlating and mappingthe specifications of a plurality of desired responses with the data asto the responses that were caused by each combination of stimulationsignals, and storing a resulting mapping in a computer-readable memory;determining that one of the plurality of conditions has occurred; andbased on the stored mapping and the determination that one of theplurality of conditions has occurred, driving the correspondingcombination of stimulation signals to evoke the desired response to thecondition in the patient.

In some embodiments of the method, the nerve-stimulation signals includean electrical-sensitization signal.

In some embodiments of the method, the plurality of VCSEL-light signalsinclude a plurality of different optical power levels and/or a pluralityof different optical wavelengths

In some embodiments of the method, the determining that one of theplurality of conditions has occurred includes: sensing a firstpatient-physiology parameter, generating a first patient-physiologysignal based on the first patient-physiology parameter, and controllingthe driving of the stimulation signals based on the firstpatient-physiology signal.

In some embodiments of the method, the determining that one of theplurality of conditions has occurred includes: sensing a firstenvironmental parameter, generating a first environmental signal basedon the first environmental parameter, and controlling the driving of thestimulation signals based on the first environmental signal.

Some embodiments of the method further includes selectively emittinglight signals having a wavelength in a range of 1.8 microns to 2 micronsand having a pulse duration from a third laser; directing the light fromthe third laser onto the first tissue; and detecting a reflected lightfrom the first tissue and determining a first physiological activity ofthe first tissue.

Some embodiments of the method the first laser is a first verticalcavity surface-emitting laser (VCSEL) and the second laser is a secondVCSEL.

Some embodiments of the method the plurality of lasers includes aplurality of vertical cavity surface-emitting lasers (VCSELs) formed ona single substrate, and the first laser is a first VCSEL formed on thesubstrate and the second laser is a second VCSEL formed on thesubstrate.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of lasers including a first laser and a secondlaser; a control circuit configured to control generation of pulsednerve-stimulation light from the first and second lasers; and alight-delivery system configured to direct the light from the firstlaser onto a first tissue of the patient, wherein the light from thefirst laser onto a first tissue of the patient is insufficient alone tostimulate a nerve action potential (NAP) in the first tissue, and todirect the light from the second laser onto the first tissue of thepatient, wherein the light from the second laser onto a first tissue ofthe patient is insufficient alone to stimulate a nerve action potential(NAP) in the first tissue, but wherein the light from the first laserand the light from the second laser intersecting onto the first tissueof the patient deliver a trigger amount of pulsed light is sufficient tostimulate a NAP in the first tissue.

Some embodiments of the apparatus further include a control circuitconfigured to control generation of a pre-charge (or sensitizationamount) current of electrical energy that is delivered during a periodof time correlated to (before and/or during) the delivery of the triggeramount of pulsed light intensity of the plurality of light signals.

Some embodiments of the apparatus further include a computer-readablestorage medium, wherein the storage medium includes instructions storedthereon for causing a suitably programmed information processor toexecute a method comprising: determining which of a first plurality ofcombinations of nerve-stimulation signals cause a reaction in thepatient and storing that information for future reference andstimulation, wherein each of the plurality of combinations ofnerve-stimulation signals include a plurality of laser-light signals,wherein the computerized method of determining includes: iterativelyapplying a plurality of different combinations of nerve-stimulationsignals to the patient and acquiring data as to one or more responsesthat were caused by each combination of stimulation signals; providingspecifications of a plurality of desired responses to each of aplurality of conditions; correlating and mapping the specifications of aplurality of desired responses with the data as to the responses thatwere caused by each combination of stimulation signals, and storing aresulting mapping in a computer-readable memory; determining that one ofthe plurality of conditions has occurred; and based on the storedmapping and the determination that one of the plurality of conditionshas occurred, driving the corresponding combination of stimulationsignals to evoke the desired response to the condition in the patient.

Some embodiments of the apparatus, the first laser is a first verticalcavity surface-emitting laser (VCSEL) and the second laser is a secondVCSEL.

Some embodiments of the apparatus, the plurality of lasers includes aplurality of vertical cavity surface-emitting lasers (VCSELs) formed ona single substrate, and the first laser is a first VCSEL formed on thesubstrate and the second laser is a second VCSEL formed on thesubstrate.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of vertical cavity surface-emitting lasers (VCSELs)including a first VCSEL and a second VCSEL; means for directing thelight from the first VCSEL onto a first tissue of the patient, whereinthe light from the first VCSEL onto a first tissue of the patient isinsufficient alone to stimulate a nerve action potential (NAP) in thefirst tissue; and means for directing the light from the second VCSELonto the first tissue of the patient, wherein the light from the secondVCSEL onto a first tissue of the patient is insufficient alone tostimulate a nerve action potential (NAP) in the first tissue, butwherein the light from the first VCSEL and the light from the secondVCSEL intersecting onto the first tissue of the patient is sufficient tostimulate a NAP in the first tissue.

Some embodiments further include a means for determining which of afirst plurality of combinations of nerve-stimulation signals cause areaction in the patient and storing that information for futurereference and stimulation, wherein each of the plurality of combinationsof nerve-stimulation signals include a plurality of VCSEL-light signals,wherein the means for determining includes: means for iterativelyapplying a plurality of different combinations of nerve-stimulationsignals to the patient and acquiring data as to one or more responsesthat were caused by each combination of stimulation signals; means forproviding specifications of a plurality of desired responses to each ofa plurality of conditions; means for correlating and mapping thespecifications of a plurality of desired responses with the data as tothe responses that were caused by each combination of stimulationsignals, and means for storing a resulting mapping in acomputer-readable memory; means for determining that one of theplurality of conditions has occurred; and means for, based on the storedmapping and the determination that one of the plurality of conditionshas occurred, driving the corresponding combination of stimulationsignals to evoke the desired response to the condition in the patient.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of vertical cavity surface-emitting lasers (VCSELs)including a first VCSEL and a second VCSEL; means for directing thelight from the first VCSEL onto a first tissue of the patient, whereinthe light from the first VCSEL onto a first tissue of the patient isinsufficient alone to stimulate a nerve action potential (NAP) in thefirst tissue; and means for directing the light from the second VCSELonto the first tissue of the patient, wherein the light from the secondVCSEL onto a first tissue of the patient is insufficient alone tostimulate a nerve action potential (NAP) in the first tissue, butwherein the light from the first VCSEL and the light from the secondVCSEL intersecting onto the first tissue of the patient is sufficient tostimulate a NAP in the first tissue.

In some embodiments of the apparatus, the apparatus further includes ameans for determining which of a first plurality of combinations ofnerve-stimulation signals cause a reaction in the patient and storingthat information for future reference and stimulation, wherein each ofthe plurality of combinations of nerve-stimulation signals include aplurality of VCSEL-light signals, wherein the means for determiningincludes means for iteratively applying a plurality of differentcombinations of nerve-stimulation signals to the patient and acquiringdata as to one or more responses that were caused by each combination ofstimulation signals; means for providing specifications of a pluralityof desired responses to each of a plurality of conditions; means forcorrelating and mapping the specifications of a plurality of desiredresponses with the data as to the responses that were caused by eachcombination of stimulation signals, and means for storing a resultingmapping in a computer-readable memory; means for determining that one ofthe plurality of conditions has occurred; and means for, based on thestored mapping and the determination that one of the plurality ofconditions has occurred, driving the corresponding combination ofstimulation signals to evoke the desired response to the condition inthe patient.

In some embodiments, the present invention provides a method and/orapparatus for selectively recruiting a first volume of neural tissuewith a first set of one or more stimulating channels and in closeproximity but without overlap providing additional sources forstimulating distinct volumes of tissue, such that multi-channel laserstimulation arrays can provide coverage of large volumes of neuraltissue without overlap. In some embodiments, one or more of the fourgeometries in FIG. 5 are used (realizing that this figure depicts onlysingle stimulating elements and that many of these could be multiplexedinto a larger system). In some embodiments of each, the inventionfurther includes materials, geometries, laser parameters, hybridoptical-electrical as well as optical-only stimulation, overlappingoptical stimulation from sources that if applied alone are insufficientto stimulate but when simultaneously applied are sufficient to triggerthe desired nerve response, and/or any other suitable embodimentsdescribed throughout the present application.

The present invention also contemplates various combinations andsubcombinations of the embodiments set forth in the above description.

As used herein, “substantially simultaneously” emitting pulsed lightfrom a plurality of sources means emitting light pulses simultaneously,at least partially overlapped in time, or emitting light pulses closeenough in time so as to cause a physiological response that is the sameas if the light pulses were emitted simultaneously.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of laser-light sources configured to generate aplurality of laser-light signals, wherein the plurality of laser-lightsources includes a first laser-light source that emits light having afirst wavelength and a second laser-light source that emits light havingthe first wavelength; one or more driver circuits that provide drivepower required to operate the plurality of laser-light sources; acontrol circuit operatively coupled to the driver circuits andconfigured to control emission of pulsed light from the first and secondlaser-light sources; and a laser-light-delivery system having at leastone pointed end and configured to deliver the plurality of laser-lightsignals independently to each of a plurality of nerves within aperipheral nerve bundle of an animal in order to independently opticallystimulate each of the plurality of nerves in the peripheral nerve bundleto trigger action potentials in the plurality of nerves, wherein atleast the pointed end of the laser-light-delivery system is configuredto be transversely implanted into the peripheral nerve bundle.

In some embodiments of the apparatus, “transversely implanted” includesinsertion at either ninety degrees relative to the longitudinal axis ofthe peripheral nerve bundle or one or more acute angles relative to thelongitudinal axis of the peripheral nerve bundle that does not parallelthe longitudinal axis of the peripheral nerve bundle. In someembodiments, the laser-light-delivery system includes two or moredelivery systems inserted into the peripheral nerve bundle at aplurality of radial (compass) directions. In some embodiments, theplurality of laser-light sources includes a plurality ofvertical-cavity-surface-emitting lasers (VCSELs) located near thepointed end including a first VCSEL and a second VCSEL, and theapparatus further includes a mechanical support system that supports theplurality of VCSELs, wherein the plurality of VCSELs are arranged on themechanical support such that when the laser-light-delivery system istransversely implanted into the peripheral nerve bundle the first VCSELis located at a first transverse depth within the peripheral nervebundle and the second VCSEL is located at a second transverse depthwithin the peripheral nerve bundle. In some such embodiments, themechanical support system is a single mechanical support and the VCSELsare arranged as a one-dimensional array along the single mechanicalsupport. In some embodiments, the mechanical support system is a singlemechanical support and the VCSELs are arranged as a two-dimensionalarray along the single mechanical support. In some embodiments, themechanical support system includes a plurality of parallel mechanicalsupports and the VCSELs are arranged as a two-dimensional array suchthat some of the plurality of VCSELs are located on each of theplurality of parallel mechanical supports. In some embodiments, themechanical support system includes a first mechanical support and asecond mechanical support, wherein a first set of the plurality ofVCSELs are supported by the first mechanical support and are configuredto deliver the plurality of laser-light signals in a first directioninto the plurality of nerves from within the peripheral nerve bundle,wherein a second set of the plurality of VCSELs are supported by thesecond mechanical support and are configured to deliver the plurality oflaser-light signals in a second radial direction into the plurality ofnerves from within the peripheral nerve bundle, and wherein the seconddirection is different than the first radial direction. In someembodiments, the mechanical support system includes a first mechanicalsupport, and wherein VCSELs supported by the first mechanical supportare configured to deliver the plurality of laser-light signals in eachof a plurality of radial directions into the peripheral nerve bundle.

In some embodiments of the apparatus, the plurality of laser-lightsources includes a plurality of vertical-cavity-surface-emitting lasers(VCSELs), and the apparatus further includes a first mechanical supportsystem configured to support the plurality of VCSELs, wherein the firstmechanical support system further includes a plurality of short opticalfibers arranged in a plurality of needle-like bundles, each opticalfiber extending from one of the plurality of VCSELs, wherein theplurality of needle-like bundles are each configured to be transverselyinserted into the peripheral nerve bundle. In some embodiments, theplurality of laser-light sources includes a plurality ofvertical-cavity-surface-emitting lasers (VCSELs), the apparatus furthercomprising a first mechanical support system configured to support theplurality of VCSELs, wherein the first mechanical support system furtherincludes a plurality of short waveguides arranged in a plurality ofneedle-like bundles, each waveguide extending from one of the pluralityof VCSELs, wherein the plurality of needle-like bundles are eachconfigured to be transversely inserted into the peripheral nerve bundle.In some such embodiments, the plurality of short waveguides includes aplurality of short optical fibers. In some such embodiments, theplurality of short waveguides is made from a material that includessilicon, a polymer, or any other suitable material. In some suchembodiments, the plurality of short waveguides is coated with an opticalcoating, or any other suitable coating. In some such embodiments, theplurality of short waveguides has a triangular-shaped pointed end or anyother suitable geometry.

Some embodiments further include an electrical cable configured toprovide an electrical connection between the one or more driver circuitsand the control circuit, wherein the control circuit is located at adistal end of the electrical cable.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of laser-light sources configured to generate aplurality of laser-light signals, wherein the plurality of laser-lightsources includes a first laser-light source that emits light having afirst wavelength and a second laser-light source that emits light havingthe first wavelength; one or more driver circuits that provide drivepower required to operate the plurality of laser-light sources; acontrol circuit operatively coupled to the driver circuits andconfigured to control emission of pulsed light from the first and secondlaser-light sources; and a laser-light-delivery system having at leastone pointed end and configured to deliver the plurality of laser-lightsignals independently to each of a plurality of nerves within aperipheral nerve bundle of an animal in order to independently opticallystimulate each of the plurality of nerves in the peripheral nerve bundleto trigger action potentials in the plurality of nerves, wherein atleast the pointed end of the laser-light-delivery system is configuredto be longitudinally implanted into a severed peripheral nerve bundle.

In some embodiments, the present invention provides a method thatincludes transversely implanting a laser-light-delivery system into aperipheral nerve bundle of an animal, the laser-light-delivery systemhaving a first pointed end inserted into the peripheral nerve bundle;generating a plurality of pulsed laser-light signals including a firstpulsed laser-light signal having a first wavelength and a second pulsedlaser-light signal having the first wavelength; and independentlydelivering the plurality of pulsed laser-light signals through thelaser-light-delivery system to each of a plurality of nerves within theperipheral nerve bundle, and, based on the plurality of pulsedlaser-light signals, independently optically triggering an actionpotential in each of the plurality of nerves in the peripheral nervebundle.

In some embodiments of the method, the plurality of laser-light sourcesincludes a plurality of vertical-cavity-surface-emitting lasers (VCSELs)located near the first pointed end of the laser-light-delivery systemincluding a first VCSEL and a second VCSEL, and the method furtherincludes mechanically supporting the plurality of VCSELs on thelaser-light-delivery system such that the first VCSEL is located at afirst transverse depth within the peripheral nerve bundle and the secondVCSEL is located at a second transverse depth within the peripheralnerve bundle. In some such embodiments, the mechanically supporting ofthe plurality of VCSELs includes arranging the plurality of VCSELs as aone-dimensional array along a single mechanical support. In someembodiments, the mechanically supporting of the plurality of VCSELsincludes arranging the plurality of VCSELs as a two-dimensional arrayalong a single mechanical support. In some embodiments, the mechanicallysupporting of the plurality of VCSELs includes arranging the pluralityof VCSELs as a two-dimensional array such that some of the plurality ofVCSELs are located on each of a plurality of parallel mechanicalsupports.

Some embodiments of the method further include providing a plurality ofmechanical supports including a first mechanical support and a secondmechanical support, wherein the first pointed end is on the firstmechanical support and a second pointed end is on the second mechanicalsupport, wherein the independently delivering of the plurality oflaser-light signals includes delivering laser-light signals from a firstsubset of the plurality of VCSELs located on the first mechanicalsupport in a first direction and delivering the plurality of laser-lightsignals from a second subset of the plurality of VCSELs located on thesecond mechanical support in a second direction.

In some embodiments of the method, the plurality of laser-light sourcesincludes a plurality of vertical-cavity-surface-emitting lasers (VCSELs)including a first VCSEL and a second VCSEL, and the method furtherincludes providing a plurality of short optical fibers configured to beinserted into the peripheral nerve bundle, wherein the plurality ofshort optical fibers are arranged in a plurality of needle-like bundles,wherein the first pointed end is an end of one of the plurality ofneedle-like bundles; and extending an optical fiber of the plurality ofoptical fibers from each one of the plurality of VCSELs.

In some embodiments of the method, the laser-light-delivery systemincludes a plurality of vertical-cavity-surface-emitting lasers(VCSELs), and the independently delivering of the plurality oflaser-light signals includes emitting laser-light signals from thelaser-light-delivery system in a plurality of non-parallel directions.

Some embodiments of the method further include delivering an electricalcurrent from a plurality of driver circuits at one end of an electricalcable to a plurality of lasers at another distal end of the electricalcable; and using the electrical current to generate the plurality oflaser-light signals from the plurality of lasers.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of laser-light sources configured to generate aplurality of laser-light signals, wherein the plurality of laser-lightsources includes a first laser-light source that emits light having afirst wavelength and a second laser-light source that emits light havingthe first wavelength; and, as described herein, means for independentlydelivering the plurality of laser-light signals to each of a pluralityof nerves within a peripheral nerve bundle of an animal in order toindependently optically stimulate each of the plurality of nerves in theperipheral nerve bundle to trigger action potentials in the plurality ofnerves, wherein the means for delivering includes a first pointed end,and wherein the means for delivering is configured to be transverselyimplanted into the peripheral nerve bundle. In some embodiments of thisapparatus, the plurality of laser-light sources includes a plurality ofvertical-cavity-surface-emitting lasers (VCSELs), wherein the pluralityof VCSELs includes a first VCSEL and a second VCSEL both located nearthe first pointed end of the means for delivering, and the apparatusfurther includes means for mechanically supporting the plurality ofVCSELs such that the first VCSEL is located at a first transverse depthwithin the peripheral nerve bundle and the second VCSEL is located at asecond transverse depth within the peripheral nerve bundle. In someembodiments of this apparatus, the means for mechanically supporting theplurality of VCSELs includes means for arranging the plurality of VCSELsas a one-dimensional array. In some embodiments of this apparatus, themeans for mechanically supporting the plurality of VCSELs includes meansfor arranging the plurality of VCSELs as a two-dimensional array. Insome embodiments of this apparatus, the plurality of laser-light sourcesincludes a plurality of vertical-cavity-surface-emitting lasers (VCSELs)located near the first pointed end of the means for delivering, whereinthe plurality VCSELs includes a first VCSEL and a second VCSEL, whereinthe means for delivering includes means for delivering the plurality oflaser-light signals of a first subset of the plurality of VCSELs in afirst radial direction and means for delivering the plurality oflaser-light signals from a second subset of the plurality of VCSELs in asecond radial direction.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of laser-light sources configured to generate aplurality of laser-light signals; and an optical-fiber bundle, whereinthe optical-fiber bundle includes a plurality of optical fibersoperatively coupled to the plurality of laser-light sources andconfigured to transmit the plurality of laser-light signals into aperipheral nerve bundle of an animal, non-invasively relative to theperipheral nerve bundle, in order to independently optically stimulateeach of a plurality of nerves in the peripheral nerve bundle such thataction potentials are independently triggered in the plurality ofnerves. In some embodiments of this apparatus, the optical-fiber bundleis configured to emit the plurality of laser-light signals from a firstend of the optical-fiber bundle located at an interface between theoptical-fiber bundle and the peripheral nerve bundle. In someembodiments of this apparatus, each one of the plurality of opticalfibers includes an emitting end configured to emit one of the pluralityof laser-light signals, wherein the plurality of emitting ends arelocated at a plurality of different locations along a longitudinallength of the optical-fiber bundle. In some embodiments of thisapparatus, each one of the plurality of optical fibers includes aninline fiber grating configured to emit its one of the plurality oflaser-light signals, wherein each one of the plurality of inline fibergratings is located at one of a plurality of different locations along alongitudinal length of the optical-fiber bundle.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of vertical cavity surface-emitting lasers (VCSELs)including a first VCSEL that emits pulsed light having a firstwavelength and a second VCSEL that emits pulsed light having the firstwavelength; one or more driver circuits operatively coupled to theplurality of VCSELs and configured to provide drive power required tooperate the plurality of VCSELs; a control circuit operatively coupledto the one or more driver circuits and configured to control emission ofthe pulsed light from the first and second VCSELs; and a cufflight-delivery system configured to wrap around neural tissue of ananimal and to direct the pulsed light emitted from the first VCSEL totrigger action potentials in a first set of one or more nerves in theneural tissue but substantially not trigger action potentials in asecond set of one or more other nerves in the neural tissue, wherein thecuff light-delivery system is further configured to direct the pulsedlight emitted from the second VCSEL to trigger action potentials in thesecond set of one or more nerves in the neural tissue but substantiallynot trigger action potentials in the first set of one or more nerves.

In some embodiments, the cuff light-delivery system includes a firstwaveguide coupled to the first VCSEL and configured to transmit thepulsed light emitted from the first VCSEL to the first set of one ormore nerves, and a second waveguide operatively coupled to the secondVCSEL and configured to transmit the pulsed light emitted from thesecond VCSEL to the second set of one or more nerves. In someembodiments, the first waveguide is a graded-index (GRIN) fiber.

In some embodiments, the first wavelength is a wavelength visible tohuman eyes. In some embodiments, the first wavelength is an infraredwavelength.

In some embodiments of the apparatus, the control circuit is integratedin a single chip with the one or more driver circuits. In someembodiments, the apparatus further includes an electrical cableconfigured to provide an electrical connection between the one or moredriver circuits and the control circuit, wherein the control circuit islocated at a distal end of the electrical cable. In some suchembodiments, the control circuit is configured to be partially implantedinto the animal such that at least part of the control circuit residesexternal to the animal.

In some embodiments of the apparatus, the VCSELs are located on an innersurface of the cuff facing the neural tissue. In some embodiments, thecuff does not completely encircle a circumference of the neural tissue.In some embodiments, the cuff completely encircles a circumference ofthe neural tissue. In some embodiments, the plurality of VCSELs isimplemented on a single semiconductor substrate. In some embodiments,the apparatus further includes a microlens integrated with each of theplurality of VCSELs to focus the light emitted from each VCSEL ontodifferent portions of the neural tissue.

In some embodiments of the apparatus, the plurality of VCSELs furtherincludes a third VCSEL that emits pulsed light having a secondwavelength, and a fourth VCSEL that emits pulsed light having the secondwavelength, wherein the control circuit is further configured to controlemission of the pulsed light from the third and fourth VCSELs, whereinthe cuff light-delivery system is further configured to direct thepulsed light from the third VCSEL to pass through the first set of oneor more nerves to trigger action potentials in a third set of nerves butsubstantially not trigger action potentials in the first set of one ormore nerves or the second set of one or more nerves, and wherein thecuff light-delivery system is further configured to direct the pulsedlight from the fourth VCSEL to pass through the second set of one ormore nerves to trigger action potentials in a fourth set of nerves butsubstantially not trigger action potentials in the second set of one ormore nerves or the first set of one or more nerves. In some embodiments,the first wavelength is in a range of 1.8 microns to 2 microns, andwherein the second wavelength is in a range of 650 nanometers to 850nanometers.

In some embodiments of the apparatus, the apparatus further includes aplurality of optical detectors including a first detector and a seconddetector, wherein the first detector is configured to detect reflectedlight from the first set of one or more nerves to determine a firstphysiological activity in the first set of one or more nerves, andwherein the second detector is configured to detect reflected light fromthe second set of one or more nerves to determine a second physiologicalactivity in the second set of one or more nerves (e.g., using light todetect the triggered action potentials). In other embodiments, theapparatus further includes a plurality of electrical detectors includinga first detector and a second detector, wherein the first detector isconfigured to detect electrical activity from the first set of one ormore nerves to determine a first physiological activity in the firsttissue, and wherein the second detector is configured to detectelectrical activity from the second set of one or more nerves todetermine a second physiological activity in the second set of one ormore nerves (e.g., using electricity to detect the triggered actionpotentials). In some embodiments, the apparatus further includes a lightdosage detector configured to detect an amount of light directed to thefirst and second set of one or more nerves in the neural tissue by theplurality of VCSELs.

In some embodiments, the present invention provides an apparatus thatincludes an array of light emitters located on a semiconductor substrateincluding a first light emitter that emits light having a firstwavelength and a second light emitter that emits light having the firstwavelength; one or more driver circuits operatively coupled to the arrayof light emitters and configured to provide drive power required tooperate the array of light emitters; a control circuit operativelycoupled to the one or more driver circuits and configured to controlemission of the light from the first and second light emitters; and acuff light-delivery system configured to wrap around neural tissue of ananimal and to direct the light emitted from the first light emitter totrigger action potentials in a first set of one or more nerves in theneural tissue but substantially not trigger action potentials in asecond set of one or more other nerves in the neural tissue, wherein thecuff light-delivery system is further configured to direct the lightemitted from the second light emitter to trigger action potentials inthe second set of one or more nerves in the neural tissue butsubstantially not trigger action potentials in the first set of one ormore nerves. In some embodiments, the array of light emitters is a VCSELarray.

In some embodiments, the present invention provides a method thatincludes providing a cuff light-delivery system configured to wraparound neural tissue of an animal, wherein the cuff light-deliverysystem includes a plurality of vertical cavity surface-emitting lasers(VCSELs) including a first VCSEL and a second VCSEL; emitting pulsedlight having a first wavelength from the first VCSEL and the secondVCSEL; directing the pulsed light emitted from the first VCSEL totrigger action potentials in a first set of one or more nerves in theneural tissue but substantially not trigger action potentials in asecond set of one or more other nerves in the neural tissue; anddirecting the pulsed light emitted from the second VCSEL to triggeraction potentials in the second set of one or more nerves in the neuraltissue but substantially not trigger action potentials in the first setof one or more nerves.

In some embodiments of the method, the method further includesidentifying which VCSELs in the plurality of VCSELs evoke desiredresponses based on the directing of the pulsed light; storing theidentification in a controller; and selectively controlling the emittingof the pulsed light from the first VCSEL and the second VCSEL based onthe stored identification in the controller. In some embodiments, themethod further includes delivering an electrical current from aplurality of driver circuits at one end of an electrical cable to acontrol circuit at another distal end of the electrical cable; and usingthe electrical current for the selectively controlling of the emittingof the pulsed light from the first VCSEL and the second VCSEL. In somesuch embodiments, the method further includes partially implanting thecontrol circuit into the animal such that at least part of the controlcircuit resides external to the animal.

In some embodiments of the method, the providing of the cufflight-delivery system includes completely encircling a circumference ofthe neural tissue with the cuff light-delivery system. In someembodiments, the providing of the cuff light-delivery system includesimplementing the plurality of VCSELs on a single semiconductorsubstrate.

In some embodiments of the method, the plurality of VCSELs includes athird VCSEL and a fourth VCSEL, and the method further includes emittingpulsed light having a second wavelength from the third VCSEL and thefourth VCSEL; directing the pulsed light from the third VCSEL to passthrough the first set of one or more nerves to trigger action potentialsin a third set of nerves but substantially not trigger action potentialsin the first set of one or more nerves or the second set of one or morenerves; and directing the pulsed light from the fourth VCSEL to passthrough the second set of one or more nerves to trigger actionpotentials in a fourth set of nerves but substantially not triggeraction potentials in the second set of one or more nerves or the firstset of one or more nerves. In some such embodiments, the firstwavelength is in a range of 1.8 microns to 2 microns, and wherein thesecond wavelength is in a range of 650 nanometers to 850 nanometers.

In some embodiments of the method, the method further includes detectingreflected light from the first set of one or more nerves to determine afirst physiological activity in the first set of one or more nerves; anddetecting reflected light from the second set of one or more nerves todetermine a second physiological activity in the second set of one ormore nerves. In other embodiments, the method further includes detectingelectrical activity from the first set of one or more nerves todetermine a first physiological activity in the first tissue; anddetecting electrical activity from the second set of one or more nervesto determine a second physiological activity in the second set of one ormore nerves. In some embodiments, the method further includes detectingan amount of light directed to the first and second set of one or morenerves in the neural tissue.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of vertical cavity surface-emitting lasers (VCSELs)including a first VCSEL and a second VCSEL; means for emitting pulsedlight having a first wavelength from the first VCSEL and the secondVCSEL; and cuff means for directing the pulsed light emitted from thefirst VCSEL to trigger action potentials in a first set of one or morenerves in neural tissue of an animal but substantially not triggeraction potentials in a second set of one or more other nerves in theneural tissue, and for directing the pulsed light emitted from thesecond VCSEL to trigger action potentials in the second set of one ormore nerves in the neural tissue but substantially not trigger actionpotentials in the first set of one or more nerves. In some embodiments,the apparatus further includes means for selectively controlling themeans for emitting the pulsed light from the first VCSEL and the secondVCSEL. In some embodiments, the first VCSEL and the second VCSEL areimplemented on a single semiconductor substrate.

In some embodiments of the apparatus, the plurality of VCSELs includes athird VCSEL and a fourth VCSEL, and the apparatus further includes meansfor emitting pulsed light having a second wavelength from the thirdVCSEL and the fourth VCSEL, wherein the cuff means further includes:means for directing the pulsed light from the third VCSEL to passthrough the first set of one or more nerves to trigger action potentialsin a third set of nerves but substantially not trigger action potentialsin the first set of one or more nerves or the second set of one or morenerves, and means for directing the pulsed light from the fourth VCSELto pass through the second set of one or more nerves to trigger actionpotentials in a fourth set of nerves but substantially not triggeraction potentials in the second set of one or more nerves or the firstset of one or more nerves.

In some embodiments of the apparatus, the apparatus further includesmeans for detecting reflected light from the first set of one or morenerves to determine a first physiological activity in the first set ofone or more nerves; and means for detecting reflected light from thesecond set of one or more nerves to determine a second physiologicalactivity in the second set of one or more nerves. In other embodiments,the apparatus further includes means for detecting electrical activityfrom the first set of one or more nerves to determine a firstphysiological activity in the first tissue; and means for detectingelectrical activity from the second set of one or more nerves todetermine a second physiological activity in the second set of one ormore nerves.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of laser light sources configured to generate aplurality of independently controlled laser light signals; a pluralityof concentric waveguide bundles including a first waveguide bundle, anda second waveguide bundle arranged around the first waveguide bundle,wherein the plurality of waveguide bundles is operatively coupled to theplurality of laser light sources, wherein the plurality of waveguidebundles is configured to emit the plurality of independently controlledlaser light signals toward a first plurality of peripheral nerves in anerve bundle of an animal in order to independently and separatelyoptically stimulate the first plurality of peripheral nerves of theanimal, wherein the first waveguide bundle includes a first plurality ofwaveguides that have a first length and are arranged around alongitudinal axis at a first radial distance from the longitudinal axis,wherein the second waveguide bundle includes a second plurality ofwaveguides that have a second length and are arranged around thelongitudinal axis at a second radial distance from the longitudinalaxis, wherein the second radial distance is larger than the first radialdistance, and wherein the first length is longer than the second length;a controller operatively coupled to the plurality of laser light sourcesand configured to selectively control the plurality of laser lightsignals emitted from each of the plurality of waveguide bundles suchthat the plurality of laser light signals provide controlled opticalstimulation to the first plurality of peripheral nerves of the animalthat triggers action potentials in the first plurality of peripheralnerves.

In some embodiments of the apparatus, the plurality of laser lightsources includes a plurality of vertical-cavity-surface-emitting lasers(VCSELs). In some embodiments, each of the first plurality of waveguidesincludes a faceted end configured to transmit its corresponding laserlight signal in a direction that is not parallel to the longitudinalaxis but is at least partially radially outward from the longitudinalaxis. In some embodiments, the first waveguide bundle is configured suchthat a face of the faceted end of each of the first plurality ofwaveguides points in a different direction that is radially-outward andlongitudinally angled with respect to the longitudinal axis. In someembodiments, the first plurality of waveguides and the first waveguidebundle are configured to reflect light out of each of the firstplurality of waveguides in a radial direction of the first plurality ofwaveguides. In some embodiments, the faceted ends of the first pluralityof waveguides are cleaved. In some embodiments, the faceted ends of thefirst plurality of waveguides are polished. In some embodiments, theapparatus is configured to be fully implanted in the animal. In someembodiments, the apparatus is a first optical stimulation device of aplurality of optical stimulation devices including the first opticalstimulation device and a second optical stimulation device, whereinlaser light signals emitted from the first optical stimulation deviceonto the first plurality of peripheral nerves is insufficient alone tostimulate a nerve action potential (NAP) in the first plurality ofperipheral nerves, and wherein laser light signals from the secondoptical stimulation device onto the first plurality of peripheral nervesof the patient is insufficient alone to stimulate a NAP in the firstplurality of peripheral nerves, but wherein laser light signals from thefirst optical stimulation device and laser light signals from the secondoptical stimulation device intersecting onto the first plurality ofperipheral nerves deliver a trigger amount of pulsed light sufficient tostimulate a NAP in the first plurality of peripheral nerves.

In some embodiments of the apparatus, the apparatus further includes afirst plurality of insulated electrical conductors extending along thefirst waveguide bundle and operatively coupled to the controller, theplurality of electrical conductors including a first electricalconductor connected to a first exposed electrode and a second electricalconductor connected to a second exposed electrode, and wherein thecontroller is configured to selectively apply an electrical signal tothe first electrical conductor and the second electrical conductor tocreate an electric field across a volume of tissue of the animal betweenthe first electrode and the second electrode. In some such embodiments,the first plurality of insulated electrical conductors further includesa third electrical conductor connected to the controller and to a thirdexposed electrode, and wherein the controller is configured toselectively and independently control an electrical field through tissueof the animal between the first electrode and the third electrode, andan electrical field through tissue of the animal between the secondelectrode and the third electrode. In some embodiments, the plurality ofelectrical conductors includes a third electrical conductor, and whereinthe controller is configured to control an electrical voltage betweenthe second electrical conductor and the third electrical conductor. Insome embodiments, the apparatus is configured to be implanted in theanimal, and configured such that when the longitudinal axis of the firstwaveguide bundle is substantially parallel to a longitudinal axis of thefirst plurality of peripheral nerves of the animal, the electric fieldsand the optical signals trigger nerve action potentials independently ineach of a plurality of the nerves in the nerve bundle. In someembodiments, the first plurality of waveguides includes a firstplurality of optical fibers and the second plurality of waveguidesincludes a second plurality of optical fibers. In some embodiments, thefirst electrode is located near ends of the first plurality of opticalfibers, and wherein the second electrode and the third electrode areboth located near ends of the second plurality of optical fibers.

In some embodiments, the present invention provides a method foroptically stimulating peripheral nerves of an animal, the methodincluding generating a plurality of independently controlled laser lightsignals; providing a plurality of waveguide bundles including a firstwaveguide bundle and a second waveguide bundle, wherein the plurality ofwaveguide bundles is operatively coupled to the plurality ofindependently controlled laser light sources, wherein the firstwaveguide bundle includes a first plurality of waveguides having a firstlength and arranged around a longitudinal axis at a first radialdistance from the longitudinal axis, wherein the second waveguide bundleincludes a second plurality of waveguides having a second length andarranged around the longitudinal axis at a second radial distance fromthe longitudinal axis, wherein the second radial distance is larger thanthe first radial distance, and wherein the first length of the firstplurality of waveguides is longer than the second length of the secondplurality of waveguides; implanting the plurality of waveguide bundlesin the animal; delivering the plurality of independently controlledlaser light signals through the plurality of waveguide bundles to thefirst plurality of peripheral nerves of the animal in order toindependently and separately optically stimulate the first plurality ofperipheral nerves of the animal; and selectively controlling theplurality of independently controlled laser light signals from theplurality of laser light sources such that the plurality of laser lightsignals provide controlled optical stimulation to the first plurality ofperipheral nerves of the animal that triggers action potentials in thefirst plurality of peripheral nerves.

In some embodiments of the method, the delivering of the plurality oflaser light signals through the plurality of waveguide bundles includesdelivering a first laser light signal through a first waveguide at afirst time and delivering a second laser light signal through a secondwaveguide at a second time, the method further comprising: identifyingwhich waveguides in the plurality of waveguide bundles evoke desiredresponses based on the delivering of the plurality of laser lightsignals; storing the identification in a controller; and basing theselectively controlling of the plurality of independently controlledlaser light signals on the stored identification in the controller. Insome embodiments, the method further includes cleaving an end of each ofthe first plurality of waveguides to form a faceted end, wherein thefaceted end is configured to transmit its corresponding laser lightsignal in a direction that is not parallel to the longitudinal axis butis at least partially radially outward from the longitudinal axis. Insome embodiments, the method further includes polishing an end of eachof the first plurality of waveguides to form a faceted end, wherein thefaceted end is configured to transmit its corresponding laser lightsignal in a direction that is not parallel to the longitudinal axis butis at least partially radially outward from the longitudinal axis.

In some embodiments of the method, the method further includesselectively controlling an electrical field through tissue of the animalbetween a first location and a second location separated from oneanother and both located along the longitudinal axis. In someembodiments, the generating of the plurality of laser light signalsincludes independently activating each of a plurality ofvertical-cavity-surface-emitting lasers (VCSELs). In some embodiments,the selectively controlling of the plurality of laser light signalsincludes controlling a pulse width of the plurality of laser lightsignals. In some embodiments, the selectively controlling of theplurality of laser light signals includes controlling a pulse repetitionrate of the plurality of laser light signals. In some embodiments, theselectively controlling of the plurality of laser light signals includescontrolling a pulse shape of the plurality of laser light signals.

In some embodiments of the method, the method further includes applyinga first precharge current of electrical energy across a first volume oftissue, and wherein the selectively controlling includes applying atrigger amount of pulsed light to each of a plurality of separate nerveswithin the first volume of tissue at one or more times following theapplication of the precharge current across the first volume of tissue.In other embodiments, the method further includes applying a firstprecharge current of electrical energy across a first volume of tissue,and wherein the selectively controlling includes applying a triggeramount of pulsed light to each of a plurality of separate nerves withinthe first volume of tissue at one or more times following theapplication of the first precharge current across the first volume oftissue; and applying a second precharge current of electrical energyacross a second volume of tissue separate from the first volume oftissue, and wherein the selectively controlling includes applying atrigger amount of pulsed light to each of a plurality of separate nerveswithin the second volume of tissue at one or more times following theapplication of the second precharge current across the second volume oftissue.

In some embodiments, the present invention provides an apparatus thatincludes a plurality of laser light sources configured to generate aplurality of independently controlled laser light signals; a pluralityof concentric waveguide bundles including a first waveguide bundle, anda second waveguide bundle arranged around the first waveguide bundle,wherein the plurality of waveguide bundles is operatively coupled to theplurality of laser light sources, wherein the plurality of waveguidebundles is configured to emit the plurality of laser light signalstoward a first plurality of peripheral nerves of an animal in order toindependently optically stimulate the first plurality of peripheralnerves of the animal, and wherein the plurality of concentric waveguidebundles is configured to be fully implanted in the animal; means fordelivering the plurality of independently controlled laser light signalsthrough the plurality of waveguide bundles to the first plurality ofperipheral nerves of the animal in order to independently and separatelyoptically stimulate the first plurality of peripheral nerves of theanimal; and means for selectively controlling the plurality ofindependently controlled laser light signals from the plurality of laserlight sources such that the plurality of laser light signals providecontrolled optical stimulation to the first plurality of peripheralnerves of the animal that triggers action potentials in the firstplurality of peripheral nerves.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Although numerous characteristics andadvantages of various embodiments as described herein have been setforth in the foregoing description, together with details of thestructure and function of various embodiments, many other embodimentsand changes to details will be apparent to those of skill in the artupon reviewing the above description. The scope of the invention should,therefore, be determined with reference to the appended claims, alongwith the full scope of equivalents to which such claims are entitled. Inthe appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein,” respectively. Moreover, the terms “first,” “second,” and“third,” etc., are used merely as labels, and are not intended to imposenumerical requirements on their objects.

What is claimed is:
 1. An apparatus comprising: a non-transitorycomputer-readable memory having a stored mapping of stimulation signalsto responses stored therein; a plurality of laser light sourcesoperatively coupled to the computer-readable memory and configured togenerate a plurality of independently controlled laser light signalsfrom selected ones of the plurality of laser light sources based on thestored mapping; a plurality of concentric waveguide bundles including afirst waveguide bundle, and a second waveguide bundle arranged toencircle the first waveguide bundle, wherein the plurality of waveguidebundles is operatively coupled to the plurality of laser light sources,wherein the plurality of waveguide bundles is configured to emit theplurality of independently controlled laser light signals toward a firstplurality of peripheral nerves in a nerve bundle of an animal in orderto independently and separately optically stimulate selected ones of thefirst plurality of peripheral nerves of the animal, wherein the firstwaveguide bundle includes a first plurality of waveguides that have afirst length and are arranged around a longitudinal axis, wherein thesecond waveguide bundle includes a second plurality of waveguides thathave a second length and are arranged around the longitudinal axis, andwherein the first length is not equal to the second length; a controlleroperatively coupled to the plurality of laser light sources andconfigured to selectively control selected ones of the plurality oflaser light signals emitted from selected ones of the first and secondplurality of waveguides, wherein the selective control of the pluralityof laser light signals provides controlled optical stimulation to theselected ones of the first plurality of peripheral nerves of the animalthat independently triggers action potentials in the selected ones ofthe first plurality of peripheral nerves; and a plurality of insulatedelectrical conductors extending along the first waveguide bundle andoperatively coupled to the controller, the plurality of electricalconductors including a first electrical conductor connected to a firstexposed electrode and a second electrical conductor connected to asecond exposed electrode, wherein the controller is configured toselectively apply an electrical signal to the first electrical conductorand the second electrical conductor to create an electric field across avolume of tissue of the animal between the first electrode and thesecond electrode.
 2. The apparatus of claim 1, wherein the plurality oflaser light sources includes a plurality ofvertical-cavity-surface-emitting lasers (VCSELs).
 3. The apparatus ofclaim 1, wherein each of the first plurality of waveguides includes afaceted end configured to transmit its corresponding laser light signalin a direction that is not parallel to the longitudinal axis but is atleast partially radially outward from the longitudinal axis.
 4. Theapparatus of claim 3, wherein the first waveguide bundle is configuredsuch that a face of the faceted end of each of the first plurality ofwaveguides points in a different direction that is radially-outward andlongitudinally angled with respect to the longitudinal axis.
 5. Theapparatus of claim 2, wherein the first plurality of waveguides and thefirst waveguide bundle are configured to reflect light out of each ofthe first plurality of waveguides in a direction that is at leastpartially radially outward from the longitudinal axis.
 6. The apparatusof claim 1, wherein the apparatus is a first optical stimulation deviceof a plurality of optical stimulation devices including the firstoptical stimulation device and a second optical stimulation device,wherein laser light signals emitted from the first optical stimulationdevice onto the first plurality of peripheral nerves is insufficientalone to stimulate a nerve action potential (NAP) in the first pluralityof peripheral nerves, and wherein laser light signals from the secondoptical stimulation device onto the first plurality of peripheral nervesof the patient is insufficient alone to stimulate a NAP in the firstplurality of peripheral nerves, but wherein laser light signals from thefirst optical stimulation device and laser light signals from the secondoptical stimulation device intersecting onto the first plurality ofperipheral nerves deliver a trigger amount of pulsed light sufficient tostimulate a NAP in the first plurality of peripheral nerves.
 7. Anapparatus comprising: a plurality of laser light sources configured togenerate a plurality of independently controlled laser light signals; aplurality of concentric waveguide bundles including a first waveguidebundle, and a second waveguide bundle arranged around the firstwaveguide bundle, wherein the plurality of waveguide bundles isoperatively coupled to the plurality of laser light sources, wherein theplurality of waveguide bundles is configured to emit the plurality ofindependently controlled laser light signals toward a first plurality ofperipheral nerves in a nerve bundle of an animal in order toindependently and separately optically stimulate the first plurality ofperipheral nerves of the animal, wherein the first waveguide bundleincludes a first plurality of waveguides that have a first length andare arranged around a longitudinal axis, and wherein the secondwaveguide bundle includes a second plurality of waveguides that have asecond length and are arranged around the longitudinal axis; acontroller operatively coupled to the plurality of laser light sourcesand configured to selectively control the plurality of laser lightsignals emitted from each of the plurality of waveguide bundles suchthat the plurality of laser light signals provide controlled opticalstimulation to the first plurality of peripheral nerves of the animalthat triggers action potentials in the first plurality of peripheralnerves; and a first plurality of insulated electrical conductorsextending along the first waveguide bundle and operatively coupled tothe controller, the plurality of electrical conductors including a firstelectrical conductor connected to a first exposed electrode and a secondelectrical conductor connected to a second exposed electrode, andwherein the controller is configured to selectively apply an electricalsignal to the first electrical conductor and the second electricalconductor to create an electric field across a volume of tissue of theanimal between the first electrode and the second electrode.
 8. Theapparatus of claim 7, wherein the first plurality of insulatedelectrical conductors further includes a third electrical conductorconnected to the controller and to a third exposed electrode, andwherein the controller is configured to selectively and independentlycontrol an electrical field through tissue of the animal between thefirst electrode and the third electrode, and an electrical field throughtissue of the animal between the second electrode and the thirdelectrode.
 9. The apparatus of claim 7, wherein the plurality ofelectrical conductors includes a third electrical conductor, and whereinthe controller is configured to control an electrical voltage betweenthe second electrical conductor and the third electrical conductor. 10.The apparatus of claim 7, wherein the apparatus is configured to beimplanted in the animal, and configured such that when the longitudinalaxis of the first waveguide bundle is substantially parallel to alongitudinal axis of the first plurality of peripheral nerves of theanimal, the electric fields and the optical signals trigger nerve actionpotentials independently in each of a plurality of the nerves in thenerve bundle.
 11. The apparatus of claim 7, wherein the first pluralityof waveguides includes a first plurality of optical fibers and thesecond plurality of waveguides includes a second plurality of opticalfibers.
 12. The apparatus of claim 11, wherein the first electrode islocated near ends of the first plurality of optical fibers, and whereinthe second electrode and the third electrode are both located near endsof the second plurality of optical fibers.
 13. The apparatus of claim 7,wherein the plurality of laser light sources includes a plurality ofvertical-cavity-surface-emitting lasers (VCSELs).
 14. The apparatus ofclaim 7, wherein each of the first plurality of waveguides includes afaceted end configured to transmit its corresponding laser light signalin a direction that is not parallel to the longitudinal axis but is atleast partially radially outward from the longitudinal axis.
 15. Theapparatus of claim 14, wherein the first waveguide bundle is configuredsuch that a face of the faceted end of each of the first plurality ofwaveguides points in a different direction that is radially-outward andlongitudinally angled with respect to the longitudinal axis.
 16. Theapparatus of claim 14, wherein the first plurality of waveguides and thefirst waveguide bundle are configured to reflect light out of each ofthe first plurality of waveguides in a radial direction of the firstplurality of waveguides.
 17. The apparatus of claim 7, wherein theapparatus is a first optical stimulation device of a plurality ofoptical stimulation devices including the first optical stimulationdevice and a second optical stimulation device, wherein laser lightsignals emitted from the first optical stimulation device onto the firstplurality of peripheral nerves is insufficient alone to stimulate anerve action potential (NAP) in the first plurality of peripheralnerves, and wherein laser light signals from the second opticalstimulation device onto the first plurality of peripheral nerves of thepatient is insufficient alone to stimulate a NAP in the first pluralityof peripheral nerves, but wherein laser light signals from the firstoptical stimulation device and laser light signals from the secondoptical stimulation device intersecting onto the first plurality ofperipheral nerves deliver a trigger amount of pulsed light sufficient tostimulate a NAP in the first plurality of peripheral nerves.
 18. Theapparatus of claim 7, wherein the controller is further configured to:selectively control the plurality of electrical conductors to apply afirst precharge current of electrical energy across a first volume oftissue, selectively control the plurality of laser light signals toapply a trigger amount of pulsed light to each of a plurality ofseparate nerves within the first volume of tissue at one or more timesfollowing the application of the first precharge current across thefirst volume of tissue, selectively control the plurality of electricalconductors to apply a second precharge current of electrical energyacross a second volume of tissue, separate from the first volume oftissue, and selectively control the plurality of laser light signals toapply a trigger amount of pulsed light to each of a plurality ofseparate nerves within the second volume of tissue at one or more timesfollowing the application of the second precharge current across thesecond volume of tissue.
 19. An apparatus comprising: acomputer-readable non-transitory memory having a stored mapping ofstimulation signals to responses stored therein; a plurality of laserlight sources operatively coupled to the computer-readable memory andconfigured to generate a plurality of independently controlled laserlight signals from selected ones of the plurality of laser light sourcesbased on the stored mapping; a plurality of concentric waveguide bundlesincluding a first waveguide bundle having a first length, and a secondwaveguide bundle having second length and arranged to encircle the firstwaveguide bundle, wherein the plurality of waveguide bundles isoperatively coupled to the plurality of laser light sources, wherein theplurality of waveguide bundles is configured to emit the plurality oflaser light signals toward a first plurality of peripheral nerves of ananimal in order to independently optically stimulate selected ones ofthe first plurality of peripheral nerves of the animal, wherein thefirst length is not equal to the second length, and wherein theplurality of concentric waveguide bundles is configured to be fullyimplanted in the animal; means for delivering the plurality ofindependently controlled laser light signals through the plurality ofwaveguide bundles to the first plurality of peripheral nerves of theanimal in order to independently and separately optically stimulate thefirst plurality of peripheral nerves of the animal; means forselectively controlling selected ones of the plurality of independentlycontrolled laser light signals emitted from selected ones of the firstand second plurality of waveguides wherein the means for selectivelycontrolling the plurality of laser light signals provides controlledoptical stimulation to the selected ones of the first plurality ofperipheral nerves of the animal that independently triggers actionpotentials in the selected ones of the first plurality of peripheralnerves; and means for creating an electric field across a volume oftissue of the animal, wherein the means for creating the electric fieldextends along the first waveguide bundle, and wherein the means forcreating the electric field is operatively coupled to the means forselectively controlling.
 20. The apparatus of claim 19, wherein theplurality of laser light sources includes a plurality ofvertical-cavity-surface-emitting lasers (VCSELs).